Navigating Alert Fatigue: A Case Study in Electronic Health Record Alert Design Optimization.

Clinical decision support (CDS) systems play a crucial role in enhancing patient outcomes, but inadequate design contributes to alert fatigue, inundating clinicians with disruptive alerts that lack clinical relevance. This case study delves into a quality improvement (QI) project addressing nursing electronic health record (EHR) alert fatigue by strategically redesigning four high-firing/low action alerts. Employing a mixed-methods approach, including quantitative analysis, empathy mapping sessions, and user feedback, the project sought to understand and alleviate the challenges posed by these alerts. Virtual empathy mapping sessions with clinical nurses provided valuable insights into user experiences. Qualitative findings, CDS design principles, and organizational practice expectations informed the redesign process, resulting in the removal of all four identified disruptive alerts and redesign of passive alerts. This initiative released 877 unactionable disruptive nursing hours, emphasizing the significance of proper alert design and the necessity for organizational structures ensuring sustained governance in healthcare system optimization.

Clinicians Leading the Design of a Patient App.

This case study describes the development of a patient facing app to aid the collection of accurate data for nursing assessment for care pathways. The project was led by service leads in co-production with a small supplier. Apps can be a user-friendly solution which enhance patient-centred care and significantly reduce service admin time. The impact shows that the innovation achieved to solve the problems identified at the outset. Digital health innovations are more successful with the engagement of users, and the authors want to encourage colleagues and services across the NHS to lead digital innovation in this case study.

Development and Evaluation of a Software Designed by a Nursing and Technology Team to Assess the Health Status of Adults over 65 Years of Age.

Objective: This work sought to develop the Actuasalud platform as a useful tool for nursing that permits assessing health, in term of frailty, in population over 65 years of age. Methods: For the design and development of Actuasalud, two working groups were formed: one from nursing with different profiles, to identify the scientific content and a computer science group responsible for the software programming and development. Both teams adapted the scientific content to the technology so that the tool would allow for population screening with detection of health problems and frailty states. Results: The software was developed in three large blocks that include all the dimensions of frailty: a: sociodemographic variables, b: comorbidities, and c: assessment tools of autonomy-related needs that evaluate the dimensions of frailty. At the end of the evaluation, a detailed report is displayed through bar diagram with the diagnosis of each of the dimensions assessed. The assessment in the participating elderly showed that 44.7% (n = 38) of the population was considered not frail, and 55.3%; (n = 47) as frail. Regarding associated pathologies, high blood pressure (67.1%; n = 57), osteoarthritis and/or arthritis (55.3%; n = 47), diabetes (48.2%; n = 41) and falls during the last year (35.3%; n = 30) were highlighted. Conclusion: Actuasalud is an application that allows nursing professionals to evaluate frailty and issue a quick diagnosis with ordered sequence, which helps to provide individualized care to elderly individuals according to the problems detected during the evaluation.

[Analysis of Field Inspection Issues and Some Suggestions for Software as Medical Device].

With the encouragement of policies and the rapid development of the biopharmaceutical industry, the number of software as medical device (SaMD) registration applications in Shanghai has continued to increase in recent years, and this paper summarizes the GMP nonconformities found in the field inspection of SaMD in Shanghai from 2020 to 2023, and the results show that nearly 70% of the problems were found in the software development process. Through in-depth analysis, this paper proposes the corresponding countermeasures for the problems found in the five most common stages such as software requirements, software design, software testing, software defect management and software configuration management, combined with the characteristics of software development. These suggested measures have certain reference significance for medical device software development and quality control personnel, and technical reviewer and inspectors.

FAIR-USE4OS: Guidelines for creating impactful open-source software.

This paper extends the FAIR (Findable, Accessible, Interoperable, Reusable) guidelines to provide criteria for assessing if software conforms to best practices in open source. By adding "USE" (User-Centered, Sustainable, Equitable), software development can adhere to open source best practice by incorporating user-input early on, ensuring front-end designs are accessible to all possible stakeholders, and planning long-term sustainability alongside software design. The FAIR-USE4OS guidelines will allow funders and researchers to more effectively evaluate and plan open-source software projects. There is good evidence of funders increasingly mandating that all funded research software is open source; however, even under the FAIR guidelines, this could simply mean software released on public repositories with a Zenodo DOI. By creating FAIR-USE software, best practice can be demonstrated from the very beginning of the design process and the software has the greatest chance of success by being impactful.

Design and evaluation of a colon cancer mobile application.

BACKGROUND: Colorectal cancer (CRC) is the third leading cause of cancer and the second cause of cancer-related deaths in the world. Despite the infrastructure and the availability of organized screening programs, participation in their screening programs is less than the set goals. Considering the importance of informing the society about the prevention and early detection of colorectal cancer symptoms and the positive impact of mobile health technologies, the present research was conducted with the aim of designing and evaluating a colon cancer mobile application. METHODS: The present research was conducted in two phases: software design and evaluation. In the first phase, the software was prepared using the cascade method. First, all the educational content related to colorectal cancer was collected through an expert panel with the participation of 10 specialists. Then the software was evaluated with alpha and beta testing, and the initial version was approved by users in terms of simplicity and usability. In the second phase, a parallel clinical randomized trial study was conducted with the aim of investigating the effect of a colon cancer mobile application on the early detection of colorectal cancer. In this stage, 204 volunteers participated; inclusion criteria were age 18-85 years, owning a smartphone and the ability to read and write. Participants were randomized into control and intervention groups. The intervention group was educated with the colon cancer application for education about colorectal cancer, and the control group was educated with a pamphlet. After education, both groups were screened for colorectal cancer symptoms, and the results were compared. RESULTS: In the software evaluation phase, the application was used by 204 users. In this stage, 84 (41.2%) women and 120 (58.8%) men, with an average (Standard Deviation) age of 47.53 (13.68) participated. Participants were randomized in two groups, 103 people with an average (Standard Deviation) age of 47.62 (14.65) in intervention group and 101 people with an average (Standard Deviation) age of 47.44 (12.70) in control group. There were no significant differences between the demographic characteristics of age, gender, marriage, occupation, instruction level, digestive disease history, cancer history, cancer risk factors, and family history of cancer between the two groups (P > 0.05). The Mann-Whitney U test indicated that there is a significant difference between the two groups of participants in self-assessment, willingness to do the screening, and the results of the assessment of colorectal cancer (P < 0.05). CONCLUSION: The results of the research indicated the positive impact of the Colon Cancer Application on the abilities of the users of self-assessment of colon cancer. Therefore, based on the findings, it can be concluded that the use of the colon cancer mobile application is effective for colon cancer prevention and self-care. TRIAL REGISTRATION: This study was registered in the Iranian Registry of Clinical Trials ( https://irct.behdasht.gov.ir ) on 13/2/2024, with the IRCT ID: IRCT20210131050189N9.

Agile eHealth Usability Evaluation: A Triangulative Approach to Promoting the Usability of eHealth Systems.

BACKGROUND: Usability evaluation is difficult to reconcile with agile software development for eHealth systems, because traditional usability evaluation is often complex and cumbersome to implement. However, obtaining prospective users' feedback during agile software development is crucial for improving the usability of eHealth systems, which is why there is an increasing need for agile eHealth usability evaluation. OBJECTIVE: This study investigates whether agile usability evaluations are suitable to evaluate patient-centered eHealth systems being agile developed in health care and are applicable for prospective users, such as older persons suffering from age-related declines. METHODS: A triangulation study was conducted combining iterative expert interviews with an exploratory case study. RESULTS: The triangulation study revealed that the implementation of an agile eHealth usability evaluation with prospective users such as older persons proved to be possible. CONCLUSION: Established eHealth usability evaluation methods must be further evolved to address age-related impairments of older persons.

A flowchart for adequate controls in virus-based monosynaptic tracing experiments identified Cre-independent leakage of the TVA receptor in RΦGT mice.

BACKGROUND: A pseudotyped modified rabies virus lacking the rabies glycoprotein (G-protein), which is crucial for transsynaptic spread, can be used for monosynaptic retrograde tracing. By coupling the pseudotyped virus with transgene expression of the G-protein and the avian leukosis and sarcoma virus subgroup A receptor (TVA), which is necessary for cell entry of the virus, researchers can investigate specific neuronal populations. Responder mouse lines, like the RΦGT mouse line, carry the genes encoding the G-protein and TVA under Cre-dependent expression. These mouse lines are valuable tools because they reduce the number of viral injections needed compared to when using helper viruses. Since RΦGT mice do not express Cre themselves, introducing the pseudotyped rabies virus into their brain should not result in viral cell entry or spread. RESULTS: We present a straightforward flowchart for adequate controls in tracing experiments, which we employed to demonstrate Cre-independent expression of TVA in RΦGT mice. CONCLUSIONS: Our observations revealed TVA leakage, indicating that RΦGT mice should be used with caution for transgene expression of TVA. Inaccurate tracing outcomes may occur if TVA is expressed in the absence of Cre since background leakage leads to nonspecific cell entry. Moreover, conducting appropriate control experiments can identify the source of potential caveats in virus-based neuronal tracing experiments.

[Design and evaluation options of multimedia applications to support the care of people with mild dementia]. / Gestaltungs- und Evaluationsmöglichkeiten von Multimediaanwendungen zur Unterstützung der Betreuung von Menschen mit leichter Demenz.

BACKGROUND: In order to cognitively and physically activate people with dementia (MMD) in institutional settings, there are numerous touch-based multimedia applications specifically designed for this target group that are actually being used in practice. In contrast, the use of similar applications in domestic settings has been relatively limited. AIM AND METHOD: This study is based on 11 expert interviews guided by questions and examines design options and requirements for application content as well as requirements for study designs to provide evidence of the effectiveness of touch-based multimedia applications for MMD and their caregiving relatives (PA). RESULTS: There is a high degree of consensus regarding the criteria for requirements for touch-based multimedia applications. Acceptance is highly dependent on user competence, usage practices, experiences and incentive structures; however, there are diverse opinions about their structural and content-related design. The quality of life is mentioned as an essential evaluation parameter for multimedia applications. DISCUSSION: The highly variable individual life circumstances of MMD and their PAs, along with limited access options and a lack of suitability of the multimedia applications, may be causal factors for their relatively limited use, especially in domestic settings. Daily performance capabilities and individual disease progression pose special requirements for the scientific evaluation and the demonstration of the effectiveness of touch-based multimedia applications.

Focal electroclinical features in generalized tonic-clonic seizures: Decision flowchart for a diagnostic challenge.

OBJECTIVE: Bilateral tonic-clonic seizures with focal semiology or focal interictal electroencephalography (EEG) can occur in both focal and generalized epilepsy types, leading to diagnostic errors and inappropriate therapy. We investigated the prevalence and prognostic values of focal features in patients with idiopathic generalized epilepsy (IGE), and we propose a decision flowchart to distinguish between focal and generalized epilepsy in patients with bilateral tonic-clonic seizures and focal EEG or semiology. METHODS: We retrospectively analyzed video-EEG recordings of 101 bilateral tonic-clonic seizures from 60 patients (18 with IGE, 42 with focal epilepsy). Diagnosis and therapeutic response were extracted after ≥1-year follow-up. The decision flowchart was based on previous observations and assessed concordance between interictal and ictal EEG. RESULTS: Focal semiology in IGE was observed in 75% of seizures and 77.8% of patients, most often corresponding to forced head version (66.7%). In patients with multiple seizures, direction of head version was consistent across seizures. Focal interictal epileptiform discharges (IEDs) were observed in 61.1% of patients with IGE, whereas focal ictal EEG onset only occurred in 13% of seizures and 16.7% of patients. However, later during the seizures, a reproducible pattern of 7-Hz lateralized ictal rhythm was observed in 56% of seizures, associated with contralateral head version. We did not find correlation between presence of focal features and therapeutic response in IGE patients. Our decision flowchart distinguished between focal and generalized epilepsy in patients with bilateral tonic-clonic seizures and focal features with an accuracy of 96.6%. SIGNIFICANCE: Focal semiology associated with bilateral tonic-clonic seizures and focal IEDs are common features in patients with IGE, but focal ictal EEG onset is rare. None of these focal findings appears to influence therapeutic response. By assessing the concordance between interictal and ictal EEG findings, one can accurately distinguish between focal and generalized epilepsies.

[Implementation and Effectiveness of Measures to Prevent Recurrence of Incidents Developed through Root Cause Analysis Using Work Flowchart].

PURPOSE: Incidents are recommended to be analyzed by root cause analysis (RCA). Our institution also conducts RCA for incidents and takes measures to prevent recurrence. The purpose of this study was to evaluate the effectiveness of countermeasures against the root causes analyzed by RCA in order to prevent recurrence of incidents. METHODS: Since the treatment planning CT scanner was replaced, incidents of failure to zero adjustment the coordinates of the bed position occurred four times during a three-month period. The RCA was used to investigate the root causes of these incidents and to formulate measures to prevent recurrence. To evaluate the effectiveness of the recurrence prevention measures, we collected the number of recurrence of incidents during the first year after the effectiveness of the recurrence prevention measures, and used the chi-square test to determine the significant difference in the probability of an incident occurring at a significance level of 5% or less. RESULTS: The measures to prevent the recurrence of incidents were to double-check that the coordinates of the bed position were adjusted to zero and to simulate operations based on a work flow that incorporated this double-check. During the first year period following the implementation of these recurrence prevention measures, the number of recurrence incidents was zero, and the probability of their occurrence decreased statistically significantly (p<0.05). CONCLUSION: Thorough double-checks and work simulation based on the work flow are effective methods for preventing the recurrence of incidents.

Effectiveness and Utility of Flowcharts on Learning in a Classroom Setting: A Mixed-Methods Study.

OBJECTIVE: Graphical representation of information organizes and promotes meaningful learning. As an example of graphical organizers, flowcharts can simplify and summarize complex information. The evidence of classroom use of flowcharts as an instructional tool is unclear. We investigated the effectiveness of flowcharts on student learning as an in-class instructional tool in a cardiovascular therapeutic course. Student experiences with the use and application of flowcharts were explored. METHODS: An explanatory sequential mixed-methods study was conducted with pharmacy students enrolled in an acute-care cardiovascular course from 2019-2021. The quantitative phase comprised a survey to determine flowchart effectiveness and a comparison of student performance in three content areas. The qualitative phase of the study used focused group interviews to understand student perceptions of flowchart use. RESULTS: Survey results indicated that using flowcharts improved understanding (110/128, 86%), integration of material (114/128, 89%), and overall knowledge (111/128, 87%). Student performance in the 3 content areas, shock, arrhythmia, and acute coronary syndrome were statistically significant with flowcharts implementation. Emerging themes from student interviews were (1) used as a medium for retention and recall, (2) used as a study tool, and (3) used as a decision-making framework. CONCLUSION: Flowcharts provide an alternative approach to teaching complex content, which allows students to organize and summarize information that promotes meaningful learning. The ease of implementation combined with the generalized nature of flowcharts makes it an effective graphical organizer that can be used across various disciplines.

Flowchart for predicting achieving the target area under the concentration-time curve of vancomycin in critically ill Japanese patients: A multicenter retrospective study.

INTRODUCTION: In therapeutic drug monitoring (TDM) of vancomycin (VCM), the area under the concentration-time curve (AUC) is related to the clinical efficacy and toxicity. Therefore, herein, we examined the factors associated with achieving the target AUC at follow-up and developed a decision flowchart for achieving the target AUC in critically ill patients. METHODS: This multicenter retrospective observational study was conducted at eight hospitals. We retrospectively analyzed data from patients who had received VCM in the intensive care unit from January 2020 to December 2022. Decision-tree (DT) analysis was performed using factors with p < 0.1 in univariate analysis as the independent variables. Case data were split up to two times, and four subgroups were included. The primary endpoint was achieving the target AUC at the follow-up TDM (AUCfollow-up) and target AUCfollow-up achievement was defined as an AUC of 400-600 µg‧h/mL. The initial AUC values were calculated with the 2-point concentrations (peak and trough) using the Bayesian estimation software Practical AUC-guided TDM (PAT). RESULTS: Among 70 patients (median age [interquartile range], 66 [56, 79] years; 50 % women), the AUCfollow-up was achieved in 70 % (49/70). Three factors were selected for the decision flow chart: predicted AUCfollow-up of 400-600 µg‧h/mL, dosing at 12-h intervals, and CCr of 130 mL/min/1.73 m2 or higher; the accuracy was adequate (92 %, R2 0.52). CONCLUSION: We successfully identified the factors associated with achieving the target AUC of VCM at follow-up TDM and developed a simple-to-use DT model. However, the validity of the findings needs to be evaluated.

Designing the Continuous Glucose Monitor Experience: An App Design Process Overview.

Users of continuous glucose monitors (CGMs) experience the product in part through software. Smartphone and watch apps empower people affected by diabetes to make real-time treatment decisions based on glucose readings and aggregate data such as medication, nutrition, and activity information. As CGMs evolve and gain greater market adoption, there's opportunity for these apps to play a greater role in users' lives and diabetes management. To do so, designers should follow the best practices established by the broader technology community and apply them to the needs of this community. The process of thorough discovery research, clear problem definition, iterative design, and testing can lower barriers toward broader adoption, and favorably influence the health of users through their mobile apps.

Diagnostic flowchart for tuberculous pleurisy, pleural infection, and malignant pleural effusion.

BACKGROUND: Several markers for the diagnosis of pleural effusion have been reported; however, a comprehensive evaluation using those markers has not been performed. Therefore, this study aimed to develop a diagnostic flowchart for tuberculous pleurisy, pleural infection, malignant pleural effusion, and other diseases by using these markers. METHODS: We retrospectively collected data from 174 patients with tuberculous pleurisy, 215 patients with pleural infection other than tuberculous pleurisy, 360 patients with malignant pleural effusion, and 209 patients with other diseases at Fukujuji Hospital from January 2012 to October 2022. The diagnostic flowchart for four diseases was developed by using several previously reported markers. RESULTS: The flowchart was developed by including seven markers: pleural ADA ≥40 IU/L, pleural fluid LDH <825 IU/L, pleural fluid ADA/TP < 14, neutrophil predominance or cell degeneration, peripheral blood WBC ≥9200/µL or serum CRP ≥12 mg/dL, pleural amylase ≥75 U/L, and the presence of pneumothorax according to the algorithm of a decision tree. The accuracy ratio of the flowchart was 71.7 % for the diagnosis of the four diseases, with 79.3 % sensitivity and 75.4 % positive predictive value (PPV) for tuberculosis pleurisy, 75.8 % sensitivity and 83.2 % PPV for pleural infection, 88.6 % sensitivity and 68.8 % PPV for malignant pleural effusion, and 33.0 % sensitivity and 60.0 % PPV for other diseases in the flowchart. The misdiagnosis ratios were 4.6 % for tuberculosis pleurisy, 6.8 % for pleural infection, and 8.3 % for malignant pleural effusion. CONCLUSION: This study developed a useful diagnostic flowchart for tuberculous pleurisy, pleural infection, malignant pleural effusion, and other diseases.

Un programa informático en la web para la evaluación dietética en Costa Rica / A web-based software for dietary assessment in Costa Rica

Introducción. La medición del consumo de alimentos es un importante indicador del estado nutricional de las personas; sin embargo, el proceso no es fácil y puede tener un nivel de error inaceptable. La incorporación de nuevas tecnologías pueden facilitar el proceso y minimizar el error. Objetivo. Desarrollar un programa informático en la web para nutricionistas que permita el ingreso de datos de consumo de alimentos con un recordatorio de 24 horas o de los 7 días anteriores, el análisis de la ingesta de energía y nutrientes y su comparación con las ingestas recomendadas; con el fin de minimizar el error en la recopilación y análisis de los datos. Materiales y métodos. Primero, se determinaron las características importantes que debe tener el programa, el cual fue elaborado posteriormente con los lenguajes de programación de Python y Javascript y con un patrón de diseño modelo-vista-controlador. Simultáneamente se crearon tres bases de datos, uno con el valor nutritivo de los alimentos, otro con datos de tamaños de porción de los mismos y otro con las recomendaciones nutricionales. Una vez elaborado, el programa fue sometido a una serie de pruebas para evaluar tanto su facilidad de uso como la exactitud de los cálculos. Resultados. Se describen las 9 etapas del programa y se justifica su diseño con evidencias de la literatura científica. Conclusiones. Se desarrolló el programa en la web, 'Dietnóstico', que permite la recolección y análisis de datos de consumo de alimentos. Una vez validado, el programa estará disponible para nutricionistas a usar en la atención nutricional y la investigación(AU)

Introduction. Assessment of food consumption is an important indicator of a person's nutritional status; however, it is not a simple process and can involve an unacceptable level of error. The application of new technologies in this process can lead to improvements and the minimization of error. Objective. To develop a computer program in the web, for nutritionists that allows the input of food consumption data using a 24- hour recall or a recall of food consumption during the 7 previous days, the analysis of energy and nutrient intake and its comparison with recommended intakes with the aim of minimizing the error involved in the collection and analysis of food consumption data. Materials and methods. The first stage was to define important characteristics to include in the programme which was developed using the programming languages of Python and Javascript and using a model-view-controller design pattern. At the same time, three databases were created: one with the nutritional value of foods, another with portion sizes of the foods and a third with the nutritional recommendations. Once created, several trials were conducted on the programme to test the operations from a user point of view, and the accuracy of the calculations. Results. The 9 stages of the software are described and its design is justified with evidence from the scientific literature. Conclusions. The program 'Dietnóstico' for use in the web, allows the collection and analysis of food consumption data. Once validated, it will be available for nutritionists involved in nutrition counselling and research(AU)

Development and diagnostic accuracy of dyslexia early identification flowchart for pediatric practice.

This study developed and evaluated the Rapid Automatized naming, Phonological Awareness, and Letter Identification (RAPALI) flowchart for early dyslexia identification in pediatric settings. Using early literacy skills at kindergarten level from the Thai emergent literacy for predicting dyslexia longitudinal study, the RAPALI flowchart effectively identified dyslexia risk at grade 3 level, boasting an AUC of 0.71, a sensitivity of 95.5%, and a negative predictive value of 99.1%. RAPALI demonstrated acceptable specificity and positive predictive value. The user-friendly flowchart aids early identification, interventions, and preventive measures for dyslexia, benefiting affected children and their families. However, further validation and adaptation are needed.

Suggested Flowchart Through Integrated C-Reactive Protein and White Blood Cell Count Analysis for Screening for Early Complications After Gastric Bypass: a Single-Center Retrospective Study.

INTRODUCTION: Early leakage detection following bariatric procedures is crucial, but a standardized evaluation method is lacking. The aim was to validate the potential benefits of postoperative day 1 (POD1) C-reactive protein (CRP) levels and white blood cell (WBC) counts in distinguishing at-risk patients following Roux-en-Y gastric bypass (RYGB) while considering the impact of obesity-related chronic inflammation. METHODS: Retrospective analysis of 261 consecutive patients aged 18-65 years with a body mass index (BMI) of 32.5-50 kg/m2 who underwent primary RYGB between 2017 and 2022. Sequential changes in CRP levels and WBC counts measured 48 h preoperatively and on POD1 morning were collected and compared between patients with/without complications and in patients without complications stratified by preoperative CRP levels. RESULTS: Female patients and those with a higher BMI tended to have higher baseline CRP levels, which were positively related to postoperative CRP. Patients experiencing complications had higher WBC counts and a higher prevalence of WBC counts >14,000/µl (77.8% vs. 25.4%; p<0.001) than those without complications. Baseline CRP ≥ 0.3 mg/dl, a longer operative time, and blood loss >10 ml were significantly more common with WBC counts above 14,000/µl; a reasonable range of change in WBC count (∆WBC) derived from its positive correlation to postoperative WBC count (r=0.6695) may serve as a useful complementary indicator. CONCLUSION: An individualized CRP threshold setting and integrated interpretation of the WBC count can be more appropriate than using static criteria for differentiating at-risk patients after RYGB. Further studies are needed to validate these findings and determine their generalizability.

[Model construction and software design of computed tomography radiation system based on visualization].

The Monte Carlo N-Particle (MCNP) is often used to calculate the radiation dose during computed tomography (CT) scans. However, the physical calculation process of the model is complicated, the input file structure of the program is complex, and the three-dimensional (3D) display of the geometric model is not supported, so that the researchers cannot establish an accurate CT radiation system model, which affects the accuracy of the dose calculation results. Aiming at these two problems, this study designed a software that visualized CT modeling and automatically generated input files. In terms of model calculation, the theoretical basis was based on the integration of CT modeling improvement schemes of major researchers. For 3D model visualization, LabVIEW was used as the new development platform, constructive solid geometry (CSG) was used as the algorithm principle, and the introduction of editing of MCNP input files was used to visualize CT geometry modeling. Compared with a CT model established by a recent study, the root mean square error between the results simulated by this visual CT modeling software and the actual measurement was smaller. In conclusion, the proposed CT visualization modeling software can not only help researchers to obtain an accurate CT radiation system model, but also provide a new research idea for the geometric modeling visualization method of MCNP.

Developing a flowchart to evaluate the use of Closed System Drug-Transfer Devices with monoclonal antibodies: Focus on the clinical trial setting.

OBJECTIVE: Available guidelines are ambiguous about safe handling monoclonal antibodies (MABs) and whether or not to use a Closed System Drug-Transfer Device (CSTD). In this article we want to describe a standardized working method on handling MABs in a clinical trial setting. DATA SOURCES: The current workflow at the clinical trial unit of the Ghent University Hospital was critically analyzed, after which an extensive literature review was performed using the National Institute for Occupational Safety and Health Working Group guidelines and the database PubMed (Keywords: monoclonal antibodies, closed system transfer devices, safety guidelines, safe handling, management, administration, (bio)compatibility, volume loss, contamination, clinical trial unit. Period: 2020-2022). DATA SUMMARY: Literature data are ambiguous. CSTDs can reduce cross-contamination and minimize exposure to potential hazardous drugs for healthcare professionals. However, in recent years more questions have been raised about their in-use compatibility and their impact on final product quality. This makes the debate on implementing CSTDs a hot topic in daily pharmacy practice and demands a holistic and standardized approach when deciding whether or not to use a CSTD when handling MABs. In a clinical trial setting, where safety data are frequently not available and the compatibility of CSTDs and investigational product is often unknown, this poses additional challenges that need to be taken into account. CONCLUSION: We developed a flowchart which standardizes the use of a CSTD when handling MABs. It allows other healthcare professionals and clinical trial sponsors to define and evaluate the necessary criteria when standardizing the position of a CSTD in their safe handling procedures.