Formal Risk Assessment Research Articles

Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based Approach.

The risk-based approach (RBA) of clinical trial was first introduced in 2011-2012. RBA necessitates implementing risk reduction activities that are proportionate to risk in order to reduce avoidable quality issues. However, there is no consistent methodology or research for identifying and evaluating risks and planning risk reduction activities. We aimed to evaluate risk reduction activities and their effects by using two risk identification and evaluation methods. Among the risk identification and evaluation methods, we selected one method with the lowest number of categories for identifying risks [risk assessment form (RAF)] and one with the highest number [risk assessment tool (RAT)]. Each method was used to identify and evaluate risks in and plan risk reduction activities for the research on ponatinib blood concentration and treatment outcome in patients with chronic phase chronic myelogenous leukemia. RAF and RAT can identify risk using abstract questions and a list of concrete risks, respectively. The sites were randomized into two groups to implement planned risk reduction activities using RAF and RAT and to compare the mean of errors and protocol deviation per subject visit between the two groups. The mean of errors per subject visit and the mean of protocol deviation per subject visit were lower in the RAF group than in the RAT group. Our study indicates that risk reductions can be successfully implemented by using a method to identify and evaluate risks in a small number of abstract categories that are critical to quality of clinical research.

Risk Assessment of Diabetes Using Diabetes Mellitus Risk Assessment form among Population of Kothanavadi Village Chamarajanagra District

Risk Assessment of Diabetes Using Diabetes Mellitus Risk Assessment form among Population of Kothanavadi Village Chamarajanagra District

An Approach to a Priori Assessment of Fuzzy Classification Models in Monitoring Tasks

The article addresses the problems of using automation tools to perform monitoring and management tasks applicable to assessing the quality of fuzzy classification models, where the classification procedure is implemented on the basis of knowledge (rules) in the absence of the training set. An approach is proposed to obtain a priori assessments of the classification quality based on the study of the used model sensitivity to changes in the values of internal parameters during the corresponding modeling. The interpretation of the modeling results in the form of risk assessment caused by the self-imperfection of the classification models is obtained. The article provides an example of a fuzzy classification model based on a comparison of the current state of a monitoring object described using fuzzy features with a set of predefined typical states, which form corresponding fuzzy equal (close) states (monitoring situations). The comparison is carried out using the fuzzy implication operation provided that the required reliability is met. The example of this model demonstrates how the type of implication operation, as well as the internal features of the model, affect the results of classification, and appropriate indicators are proposed, which are both an interpretation of generally accepted indicators for assessing the classification quality, and unique, inherent in the considered model. Computational experiments were carried out, which made it possible to obtain graphs of changes in classification quality assessment indicators for the considered model and its modification and visualize the influence of internal parameters of the model on the results of its application. A number of indicators are proposed that allow for an a priori assessment of the risks arising from the application of the model before its actual application.

Cross-contamination Risk Assessment using FMEA tool

In pharmaceutical manufacturing facilities, products with different therapeutic properties and potencies are manufactured in shared spaces, which poses a potential risk for cross-contamination. During the manufacturing process, cross-contamination may occur due to the uncontrolled release of dust, gases/vapors, mix-ups with other materials, residues on equipment, and contamination from operator’s clothing. By implementing adequate facility design and manufacturing operations aligned with Quality Risk Management principles, the risk of cross-contamination can be controlled. If a shared facility is used for manufacturing pharmaceutical products, strategic controls for identifying and managing the risks of cross-contamination should be in place. This article provides a structured and systematic framework for the risk-based identification of the worst-case product and manufacturing process among the products manufactured in the solid oral facility, addressing the high risk of cross-contamination. Keywords: Cross-contamination, Contamination, Risk Assessment, Formal risk assessment, Quality Risk Management (QRM), Failure Mode Effect Analysis (FMEA), Oral Solid Dosage (OSD), Worst case, Contamination Control Strategies (CCS)

EP349 - Use of Pre-operative Risk and Frailty Assessment in patients undergoing Emergency Laparotomy

Abstract Aims Formal preoperative assessment of risk of complications and death in all patients undergoing Emergency Laparotomy is recommended by NELA (National Emergency Laparotomy Audit) in the UK. In addition, frailty assessment in patients who are 65years or older and frail undergoing Emergency Laparotomy is also recommended. In a previous 2018 audit, we had recorded Preoperative Mortality Risk in 77% patients undergoing Emergency Laparotomy and Frailty was not part of our assessment in these patients. In this audit our aim was to evaluate documentation of preoperative frailty and risk assessment in patients undergoing Emergency Laparotomy from 2019 to 2023. Methods Details of all patients who underwent Emergency Laparotomy at a University Hospital under care of one surgical team between January 2019 and December 2023 were obtained from theatre logbooks. Patient notes were retrospectively reviewed to see if frailty assessment and preoperative risk assessment scores were recorded. This data was collected and analyzed using Microsoft Excel. Results During this period, sixty-seven patients were identified. The median age was sixty-seven with an age range from four to ninety-one. Of these 38 (57%) were females. A preoperative p-possum score was documented in 59 (88.1%), 39 (58.2%) patients were 65 years or older of these 26 (66.7%) had frailty assessment carried out. Conclusions Our data suggests that we have over time made progress in the use of Perioperative Risk assessment scores and incorporated frailty assessment in our perioperative practice in patient’s undergoing Emergency Laparotomy. However there remains room for improvement.

EP465 - Transfusion Associated Circulatory Overload (TACO) Audit - A prospective analysis of adherence to standards ensuring safe transfusions

Abstract Aims TACO is defined as acute or worsening respiratory compromise during or up to 12 hours of transfusion, with additional features including cardiovascular system changes not explained by the patient’s underlying medical condition. In the UK, TACO remains a major cause of Morbidity in surgical post operative patients. The aim of this audit was to assess whether the current trust transfusion practices are synchronous with the NICE guidelines and SHOT recommendations. Methods We reviewed 27 incidences of transfusion during the whole month in acute general surgical ward. Patient’s notes, trust intranet and EPMA were used for data collection. The adherence to Ng24 as well as latest SHOT recommendations was checked. Following standards were taken into account: A formal pre-transfusion risk assessment for transfusion-associated circulatory overload (TACO) should be undertaken for all patients receiving blood transfusion and mitigating actions taken. (Serious hazards of transfusion SHOT recommendation) Patients who develop respiratory distress during or up to 24 hours following transfusion where transfusion is suspected to be the cause must be reported to SHOT. A structured incident review should be undertaken for every case of TACO. Weight-adjusted red cell dosing should be used. (NICE Guidelines Ng24) Result TACO assessment checklist was only completed for 15% of transfusions (compared to 35% nationally) while mitigation actions were only considered for 4% of patients. There appeared discordance among junior doctors regarding TACO Management. Conclusions Interventions like teaching sessions, information leaflets and posters, presentation for induction pack and liaison with Transfusion practitioner team to modify transfusion pathway significantly reduced inconsistencies regarding safe transfusions and immensely improved patient management.

Understanding Musculoskeletal Risks in Retail Workers: An Ergonomic Assessment of Store 24H

Musculoskeletal disorders (MSDs) are prevalent in retail environments, often resulting from repetitive tasks, awkward postures, and prolonged standing. This study examined musculoskeletal discomfort and ergonomic risk factors within the retail environment of convenience stores, focusing on the prevalence of MSDs among employees of Store 24H, Dungun, Terengganu, Malaysia. The assessment began with a job task description, followed by workplace observation and worker input. Utilising a systematic approach, the research integrated two standardized assessment tools; the Cornell Musculoskeletal Questionnaire (CMQ) and the Initial Ergonomic Risk Assessment (ERA) Form Checklist, to identify the discomfort area and ergonomic risk factors associated with job tasks. Three job tasks were identified in the Store 24H environment; operating cash registers, customer service and restocking. The findings indicate a notable prevalence of MSDs associated with the identified high-risk tasks. Repetitive motions, awkward postures, prolonged standing, and forceful exertion were observed as primary ergonomic risk factors for these tasks which contribute to musculoskeletal discomfort in the neck, shoulder, back, hip, and knee. Additionally, forceful exertion and vibration exhibit high risks towards restocking tasks, resulting in restocking as the top contributor towards the MSDs. Hence, the findings highlight the need for advanced ERA and mitigation strategies, including workstation redesign, task rotation, ergonomic training and accessories, to promote employee well-being and reduce the incidence of MSDs among employees of Store 24H. Implementing these measures is essential for promoting the health and well-being of employees, decreasing the occurrence of musculoskeletal disorders, and improving overall safety and productivity in the workplace.

Genetic Counselors' attitudes & perceptions regarding suicide risk assessment and identification in practice.

While the heritability of suicidal tendencies is debated, receipt of various genetic diagnoses has shown an increased risk of suicidal ideation and behavior while simultaneously conferring risk to mental health concerns that may further increase this risk. However, the role of genetic counselors (GCs) in assessing and addressing suicide risk remains underutilized. A 15-item recruitment survey was distributed via the National Society of Genetic Counselors Student Research Survey Listserv, and interested individuals could opt to be contacted for an interview after completion. The data analysis included 107 survey responses and 15 semi-structured interviews, which were conducted to explore whether GCs feel that formal suicide risk assessment (SRA) falls within their scope of practice and the frequency with which it is employed during counseling sessions. Additionally, the study examined GCs' experiences, comfort levels, and training in assessing for suicide risk. All interviews were transcribed verbatim and independently coded by two researchers. The coding scheme was systematically constructed, integrating both deductive and inductive coding methods to inform the authors' interpretive description of SRA in the clinic, with four major themes identified by content analysis. Most respondents reported that they had worried about a patient harming themselves or having suicidal thoughts. Most respondents agreed or strongly agreed that SRA is within a GC's scope of practice. Lack of training emerged as the primary barrier to assessing suicide risk and conducting risk assessments. Other barriers included low self-efficacy, societal stigma, and personal discomfort, while access to social workers, natural inclination, and standardized screening tools served as facilitators. Despite encountering patients at risk of self-harm and suicide, most GCs do not utilize SRA tools. Furthermore, GCs expressed a strong desire for additional training to enhance their skills in identifying and managing at-risk patients. A multifocal approach to suicide risk reduction and education is required.

Application of Analytical Quality by Design to the development and validation of reduced and non-reduced capillary electrophoresis analytical procedures for mAb purity determination

Capillary electrophoresis-sodium dodecyl sulfate (CE-SDS) is a common analytical procedure used to quantitate critical quality attributes relating to the purity and glycosylation of monoclonal antibodies (mAbs). In this study, the application of an Analytical Quality by Design framework incorporating Design of Experiments was used to develop and validate both non-reduced (CE-NR) and reduced (CE-R) versions of this analytical procedure. Formal risk assessments were used to identify critical method attributes for optimization based on their potential impacts to performance criteria outlined in an analytical target profile. The resulting response surfaces connecting these critical factors to method performance were then utilized to generate a harmonized procedure to reduce execution risk across CE-R and CE-NR applications. Validation of these procedures according to regulatory guidelines support that they meet their required performance criteria, and a multivariate assessment of procedure robustness indicates that method parameters are in a sufficient state of control to ensure appropriate quantitation of mAb quality. Overall, this study demonstrates the utility of adopting an Analytical Quality by Design framework to leverage multidimensional knowledge from multiple critical method parameters to ensure an analytical procedure is fit-for-purpose.

Development of a Preoperative Screening Tool to Reduce Morbidity and Mortality of COVID-19-positive Hepatobiliary Patients

PurposeThis study aimed to create a preoperative risk assessment form for COVID-19-positive hepatobiliary patients to guide further prevention of complications after surgery and reduce morbidity and mortality. DesignBased on the literature, focus groups, and case studies, a multidisciplinary panel of 15 experts conducted three rounds of a Delphi study that resulted in the development of a preoperative risk assessment form to be used by healthcare professionals in the treatment of COVID-19-positive hepatobiliary patients. MethodsA preoperative risk assessment form for health professionals to use among COVID-19-positive hepatobiliary patients was developed based on literature, focus groups, and case studies. A 3-round Delphi study was conducted to validate and revise the risk assessment form using a multidisciplinary panel of 15 experts involved in hepatobiliary surgery. FindingsThe experts demonstrated high cooperation and familiarity with the research topic, with positive coefficients ranging from 93.33% to 100% and authority coefficients ranging from 0.83 to 0.86. The coordination coefficients were 0.33, 0.26, and 0.22, respectively, indicating good coordination among expert opinions. The final risk assessment form included 9 primary (first-level) indicators, 38 secondary (second-level) indicators, and 122 tertiary (third-level) indicators. ConclusionsThe preoperative risk assessment form for hepatobiliary surgery patients infected with COVID-19 is scientifically rigorous, reliable, and valid. This screening tool may be used by health providers to identify high-risk patients, prevent postoperative complications, and reduce morbidity and mortality.

524 Outcomes From Preoperative Risk Scoring for Emergency Laparotomy

Abstract Aim Risk scoring systems can be used to predict outcome, facilitate perioperative decision making and guide management in emergency laparotomy (EL). This study aims to evaluate the differences in outcome between EL patients who were prospectively risk assessed and those who were not. Method A retrospective study was conducted on all 782 patients aged over 18 years who underwent EL at four Australian hospitals between 1 January 2018 and 31 December 2019. Data recorded included demographics, preoperative risk assessment, case urgency, involvement of anaesthetic and intensive care consultants, critical care bed requirement, mortality, and discharge destination. NELA scores were retrospectively calculated for all patients. Results 209 patients had been preoperatively risk assessed, with a mean NELA score of 16.45%, compared to 8.72% for those who were not preoperatively risk assessed. They tended towards a higher ASA score, were booked as a higher urgency operation, and were more likely to receive consultant led care by anaesthetics and intensivists. Postoperatively these patients had increased critical care bed utilisation, 30-day mortality was 14.4% compared to 5.8%, and by 365 days mortality rose to 24.9% compared to 13.8%. Conclusions Use of preoperative risk prediction scores does not in itself reduce risk of mortality. In a health system that does not mandate formal preoperative risk assessment, it appears that clinicians use preoperative risk assessment tools when they perceive risk to be higher, rather than as a routine part of emergency laparotomy care.

The role of intuition in social work practice: differing understandings and attitudes

ABSTRACT There has been a long debate about the use of intuition in helping professions, including social work. Often viewed negatively in professional contexts, intuition is nonetheless used as a form of risk assessment. The current research examined methods of identifying child sexual abuse. A mixed methods approach was taken, with 98 participants completing an online questionnaire and 24 taking part in in-depth interviews. The participants demonstrated varied perceptions of intuition and its usefulness. Although some participants were strongly critical of its use, for others, intuition or ‘gut feelings’ were preferred to formal assessment tools. However, what was discussed as intuition, rather than a form of ‘sixth sense’, was often based on tacit knowledge; for example, abused young people’s observable behaviours combined with known risk factors such as certain family characteristics. Therefore, concerns about the use of intuition may be based on incorrect assumptions.

Communicating cardiovascular health information and improving coordination with primary care: A Childhood Cancer Survivor Study randomized trial.

10011 Background: Childhood cancer survivors are at risk of early cardiovascular disease (CVD). We conducted a survivorship care plan (SCP)-based counseling intervention to improve CVD risk factor control in adult-aged survivors. Methods: Randomized (1:1) trial of survivors at high CVD risk based on history of anthracycline or chest radiotherapy exposures with undertreated hypertension (≥130/80 mmHg), dyslipidemia (LDL ≥160 mg/dL or triglyceride ≥200 mg/dL), and/or glucose intolerance (threshold varied if history of pre-diabetes or diabetes) based on in-home testing. Approximating a survivorship clinic visit, the intervention consisted of a remotely delivered session with an advanced practice provider to review results, a SCP with personalized CVD risk information, and an action plan to help manage CVD risk factors. A remote booster session was provided 4 months later with the action plan updated. Control participants only received a copy of their in-home results with abnormalities noted and written encouragement to follow-up with their primary care provider (PCP). Blood pressure, lipid profile, and glucose tolerance were retested after 1y. For both groups, all participant materials were sent to PCPs throughout the study, and PCP medical records were abstracted at study completion. Logistic regression assessed the odds ratio (OR) for undertreatment at 1y associated with the intervention, adjusting for pre-specified variables (sex, current age, time since cancer, insurance status, recent history of survivorship clinic visit, and undertreated CVD risk factor). Results: Among 644 survivors who completed in-home testing, 347 met inclusion criteria and were randomized (175 intervention; overall 52% male, mean age 40y, 31y since cancer diagnosis); 264 with 1y follow-up (126 intervention). At baseline, rates of hypertension, dyslipidemia, and glucose intolerance were 53%, 52%, and 49%, respectively; 43% had > 1 undertreated condition. Although the intervention achieved > 95% satisfaction, it was not associated with reduced undertreatment vs control (OR 0.9, 95% CI 0.7-1.3). Notably, 48% of intervention and 44% of control participants had less undertreatment after 1y. In secondary analysis, greater internal locus of control was associated with less undertreatment at 1y (OR 0.7, 95% CI 0.6-0.9). The intervention group was more likely than controls to have CVD risk (+10 vs -1%), SCP (+17 vs -2%), and some late effects surveillance plan (+8 vs +2%) documented within PCP records at 1y vs baseline (p < 0.05 for all). Conclusions: While a remotely delivered counseling intervention did not reduce CVD risk factor undertreatment compared with provision of test results alone, both study arms had > 40% reduction in undertreatment. These results suggest that simply providing a formal CVD risk assessment to high-risk cancer survivors and their PCPs may be effective. Clinical trial information: NCT03104543 .

Insulin Resistance in Systemic Lupus Erythematosus

The objective: to analyze the frequency of insulin resistance (IR) in patients with systemic lupus erythematosus (SLE), study of traditional and rheumatic disease-related risk factors for the development of IR, assessment of the possibility of using of Finnish Type 2 Diabetes Risk Assessment Form (FINDRISC) to detect IR. Materials and methods. 58 patients with SLE (53 women and 5 men) without diabetes mellitus (DM) and hyperglycemia were included in the one-time study. The patients have received the inpatient treatment at the regional medical and diagnostic center of the communal enterprise “Poltava Regional Clinical Hospital named after M. V. Sklifosofsky PRC” in 2020-2023. The average age of patients was 38 [28; 43] years, the average duration of the disease is 4.0 [0.6; 6.0] years. 49 (85%) patients received glucocorticoids (GC), 20 (34%) – hydroxychloroquine, 26 (45%) – immunosuppressants, 2 (3%) persons received biological drugs. In all patients fasting glucose and insulin levels were determined, and the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) index was calculated. The value of the HOMA-IR index ≥2.77 corresponded to the presence of IR. Traditional risk factors for type 2 DM and the risk of its development in the next 10 years in patients with SLE were assessed using the FINDRISC questionnaire. Results. IR was determined in 14 (24%) of 58 patients with SLE. The average value of the HOMA-IR index was 1.8 [1.3; 2,6]. The data of patients with and without IR were similar in terms of sex, age, duration and activity of SLE, therapy performed at the time of examination, frequency of traditional risk factors for type 2 DM. Body mass index (BMI), waist circumference (WC), and insulin concentration were higher in patients with IR. The HOMA-IR index was correlated with BMI (r=0.7; p<0.001), WC (r=0.6; p<0.001), risk categories for the development of type 2 diabetes according to FINDRISС (r=0.4; p=0.04), the SLEDAI-2K index (r=–0.3; p<0.02), the serum concentration of C3 complement (r=0.4; p=0.035) and the duration of GC therapy (r=0.4; p=0.02). Conclusions. IR was diagnosed in 24% of patients with SLE without a history of DM and with a normal fasting venous blood glucose level. The HOMA-IR index increased as SLE activity decreased and the duration of GC treatment increased. However, the development of IR was statistically significantly associated only with an increase in BMI and WC. The use of the FINDRISC questionnaire, which allows to assess the risk of developing type 2 DM in the general population, did not help to detect IR in patients with SLE.

Analytical Quality by Design as applied to the development of a SEC-HPLC platform procedure for the determination of monoclonal antibody purity without mobile phase additives

This work presents the application of AQbD principles to the development of a size exclusion chromatography (SEC) HPLC procedure for the determination of monoclonal antibody (mAb) product purity using state-of-the-art column technology available via the Waters™ XBridge Premier Protein SEC column. Analytical Quality by Design (AQbD) emphasizes a systematic, risk-based lifecycle approach to analytical procedure development based on sound statistical methodologies. It has recently become increasingly recommended by regulatory agencies as a response to the need for greater efficiency, improved reliability, and increased robustness among modern analytical procedures in the pharmaceutical industry. Use of an Analytical Target Profile (ATP) and formal risk assessments informed the application of Design of Experiments (DoE) to optimize this analytical procedure, as well as assess its robustness and ruggedness. Importantly, our ruggedness results demonstrated the transferability of this procedure between two laboratories within the Catalent Biologics Global Network. Application of this analytical procedure as a platform approach for evaluating mAb purity is expected to support expedited, first-in-human timelines of mAb molecules by enabling great quantitative performance with simple mobile phase buffer compositions. Taken together, this case study demonstrates the utility of adopting AQbD principles in analytical procedure development.

Audit of VTE prophylaxis risk assessment and prescribing for general medical inpatients

Venous thromboembolism is a significant cause of morbidity and mortalityamongst hospitalised patients. The aim was to review the current level ofcompleteness of venous thromboembolism (VTE) prophylaxis risk assessmentdocumentation at Surrey and Sussex Healthcare NHS Trust. TheVTE prophylaxis risk assessment form is provided on Cerner and all doctorsare prompted to complete this when opening a patient record. The riskassessment proforma ensures that all patients who are assessed as either atmoderate or high risk of VTE during their admission receive pharmacologicalVTE prophylaxis or if contraindicated mechanical prophylaxis. Usingthe Trusts thromboprophylaxis guideline, six standards were defined. Thetarget for each standard is set at 100% and complies with national auditstandards for preventing hospital acquired VTE and PE. Results are shown further in the text:Ninety three per cent of admissions had documented assessments onadmission to hospital. 0.03% had VTE risk reassessed within 24 h- and some of these patients would have gone to other wards first, 12.5% had24 h reassessment documented which did not meet national targets.Limitations faced included: limited timeframe of data collection, smallsample size and prophylaxis could have been prescribed, but the clinicianhad not recorded the assessment on the electronic record (Cerner).These findings have been presented to our local general internal medicinedepartment. We plan to reaudit VTE compliance on another GIM ward.We expect findings to be similar; therefore we plan to implement a changeto improve compliance rates to the national standard. We will then reauditwithin 6 months to see if we have improved. I’m looking forward tothe results!

Abstract PO1-20-01: A Prospective Single-Arm Pilot Interventional Trial to Assess Individual Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery

Abstract Background: The number of individuals who identify as transgender and/or gender-diverse (TGD) is steadily increasing and the number of individuals seeking chest masculinization surgery, commonly called “top-surgery,” is also increasing. In persons assigned female at birth, top surgery removes most breast tissue to allow the chest to appear masculine. However, top surgery is not equivalent to oncologic risk-reducing mastectomies (RRM), which aim to remove all breast tissue to reduce future breast cancer (BC) risk. While top surgery has significant psychological and health benefits, its impact on future BC risk is unclear, especially for those individuals who are at high-risk for future BC development (defined as ≥17% by international consensus guidelines) and/or have a pathogenic germline mutation for BC. The aims of this study are to 1) determine the percentage of TGD persons assigned female at birth who are considering undergoing top surgery and are at elevated BC risk using validated risk models, 2) determine the percentage of TGD persons at elevated BC risk who choose to undergo RRM as part of top surgery, and 3) assess and compare self-perceived BC risk compared to calculated risk. Methods: A single-institution prospective single-arm pilot study is currently underway from March 2023 through January 2024. Individuals assigned female at birth, who are age ≥18 years, and considering undergoing top surgery, but have not yet undergone top surgery, are eligible to enroll (goal accrual N=35). Participants are being actively recruited form our institution’s Comprehensive LGBTQIA+ Inclusion Health Clinic and Plastic Surgery Clinic. Consented participants undergo a personalized BC risk assessment the validated IBIS and Gail (for those ≥35 years old) BC risk models. Those with an average lifetime BC risk (< 17%) are recommended to continue top surgery as planned/no intervention, participants with a moderate lifetime BC risk (17-30%) are counseled they may consider RRM as part of their top surgery operation given that sparse data exists in this space, while those with a high lifetime BC risk ( >30% or pathogenic germline variant) are counseled on the potential benefits of RRM. Participants with a family history suggestive of a hereditary cancer syndrome meet with a certified Genetics counselor for consideration of genetic testing, per NCCN guidelines. Results: We anticipate reporting 1) general demographic description of the cohort, 2) the percentage who have an elevated lifetime BC risk and/or a pathogenic genetic mutation, 3) the percentage of those with an elevated risk who choose to undergo RRM as part of top surgery, and 4) report the differences between self-perceived vs calculated lifetime BC risk. Conclusion: Our findings will inform TGD persons and surgeons on the utility of a personalized BC risk assessment prior to top surgery to assist in surgical decision-making, report the accuracy of self-perceived BC risk in TGD persons, and potentially change the standard pre-operative evaluation for TGD persons considering top surgery to include a formal BC risk assessment to ensure high-risk individuals have the option to undergo RRM to appropriately reduce their future BC risk. Citation Format: Chandler Cortina, Anna Purdy, Samantha Stachowiak, Kristen Klement, Sarah Sasor, Kate Krucoff, Andrew Petroll, Kevin Robertson, Annie Lakatos, Erin Doren. A Prospective Single-Arm Pilot Interventional Trial to Assess Individual Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-20-01.

Determination of Breast Cancer Risk and Knowledge Levels in Women: The Case of Cyprus.

Breast cancer is the type of cancer that is seen all over the world and ranks first among female cancers in terms of incidence and cause of death. This research was conducted to determine the breast cancer risk level and breast cancer knowledge level in women living in Northern Cyprus. The study, which was planned as a relational survey, was carried out as web-based. The research was completed with 657 adult female participants living in Northern Cyprus who volunteered to participate in the study. In order to collect data, the first section includes the introductory features, the second section includes the "Breast Cancer Risk Assessment Form" for determining breast cancer risk levels, the third section includes the "Comprehensive Breast Cancer Knowledge Test" to determine the breast cancer knowledge levels of the participants, and the fourth section includes the "Champion Health Belief Model Scale" was used. It was determined that 95.2% of women were in the low risk group for breast cancer. The knowledge test mean score is 12.05, and it can be said that the scores obtained are above the average (min:4- max:18). It was found that 55.7% of the women knew how to do Breast Self-Examination (BSE), but only 15.4% of them regularly performed BSE every month. It was found that 80.9% of the women never had mammography and their knowledge scores increased with increasing education level (p< 0.001) and there was a significant relationship between non-smokers and their knowledge levels (p< 0.01). Despite the high scores of women in knowledge tests, it was observed that the frequency of applying BSE and having mammography was very low. Regardless of the risk factors for breast cancer, the importance of regular check-ups and BSE for every woman should be taught to women by health professionals, and group trainings should be planned for women who do not have training on this subject.

Illuminating the dark side: Life story and formulation work to understand criminogenic capacities and human harmfulness

The assessment of risk is a central component of forensic practice with clinicians regularly being required to undertake formal risk assessments using Structured Professional Judgment tools. While these tools guide practitioners to identify areas of concern, they do little to establish the function of risk factors or the context(s) that influenced the consolidation of harmful capacities. In this paper we argue for a compassionate approach to risk assessment that incorporates a functional analysis of the influence of learning experiences and promotes insight into the initial function of risks. We attempt to illustrate this process using case studies throughout.

Modifications of the Formal Risk Analysis and Assessment for the Information System Security

Modifications of the Formal Risk Analysis and Assessment for the Information System Security