A method for empirically validating FMEA RPN scores in a radiation oncology clinic using physics QC data.

In failure modes and effects analysis (FMEA), the components of the risk priority number (RPN) for a failure mode (FM) are often chosen by consensus. We describe an empirical method for estimating the occurrence (O) and detectability (D) components of a RPN. The method requires for a given FM that its associated quality control measure be performed twice as is the case when a FM is checked for in an initial physics check and again during a weekly physics check. If instances of the FM caught by these checks are recorded, O and D can be computed. Incorporation of the remaining RPN component, Severity, is discussed. This method can be used as part of quality management design ahead of an anticipated FMEA or afterwards to validate consensus values.

Comparison of the Response to an Electronic Versus a Traditional Informed Consent Procedure in Terms of Clinical Patient Characteristics: Observational Study.

BACKGROUND: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals. OBJECTIVE: We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC). We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure. METHODS: All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the learning health care system. From November 2021 to August 2022, an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Responses (ie, consent, no consent, or nonresponse) were assessed and compared between the eIC and face-to-face IC cohorts. Clinical characteristics of consenting and nonresponding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses. RESULTS: A total of 2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9% vs 876/2254, 38.9%, respectively). Apart from lower mean hemoglobin in the full consent group of the eIC cohort (8.5 vs 8.8; P=.0021), the characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohorts. In the eIC cohort, only age differed between the full consent and the nonresponse group (median 60 vs 56; P=.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (ie, higher hemoglobin, lower glycated hemoglobin [HbA1c], lower C-reactive protein levels) than the nonresponse group. CONCLUSIONS: More patients provided full consent using an eIC. In addition, the study population remained broadly similar. The face-to-face IC approach seemed to result in a healthier study population (ie, full consenting patients) than the patients without IC, while in the eIC cohort, the characteristics between consent groups were comparable. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results.

Risk management of radioiodine treatment in differentiated thyroid cancer.

INTRODUCTION: Patient safety is paramount in providing quality healthcare and constitutes a global concern for healthcare systems. Radioiodine treatment to patients with well-differentiated thyroid cancer is not without risks. The aim of this study is to identify, evaluate and mitigate the risks associated with this procedure. MATERIALS AND METHODS: A single-centre descriptive study was conducted in which risk management was carried out by establishing a risk map using FMEA methodology. RESULTS: Based on the process map 6 sub-processes and 23 failure modes in the three phases of the treatment process were analysed. According to risk priority number (RPN), the sub-process with the highest risk was administrative management (RPN 82), followed by treatment per se and post-treatment imaging (both with RPN 70). An overall process RPN of 300 (156 pre-treatment, 74 treatment and 70 post-treatment) was obtained. Failures directly related to the patient pose a high risk. The implementation of verification systems, performing tasks earlier and providing quality medical information are the most relevant preventive measures to be implemented. CONCLUSIONS: The application of the FMEA methodology in the risk management for radioiodine treatment is a valuable tool for improving the quality and safety of this process. The risk map has been able to identify failures at different stages, assess their causes and effects, prioritise the risks identified and implement preventive and corrective measures that can be monitored, ensuring the effectiveness of the actions taken.

Monitoring the Effectiveness of High-Fluence Peripheral Crosslinking for Corneal Neovascularization with Anterior Segment Optical Coherence Tomography Angiography.

Background/Aims: To investigate the effectiveness of an accelerated high-fluence peripheral crosslinking (pCXL) treatment protocol for corneal neovascularization (cNV) and the viability of optical coherence tomography angiography (OCTA) to monitor cNV dynamics. Methods: This pilot study included six eyes of six adult patients with cNV in at least one corneal quadrant who were treated with pCXL (7.2 J/cm2, 9 mW). The degree of cNV regression was monitored with slit lamp photography and anterior segment OCTA. The main outcome measure was total vessel area one and four weeks after treatment. Results: OCTA allowed for the objective monitoring of vascular metrics: The total vessel area declined from an average of 1025.4 mm2 (min: 0.13 mm2; max: 3637 mm2) at the baseline evaluation to 382.4 mm2 (min: 0.08 mm2; max: 1528 mm2) (p = 0.096). The total vessel length lessened from an average of 107.1 mm (min: 2.8 mm; max: 321.1 mm) to 47 mm (min: 2.6 mm; max: 156.5 mm) (p= 0.27). The average number of junctions at baseline decreased from 46.67 (min: 3; max: 166) to 26.5 (min: 0; max: 50) (p = 0.23). The junction density decreased from an average of 10.75/mm2 (min: 0.0002 /mm2; max: 36.5056/mm2) to 7.37/mm2 (avg.) (min: 0; max 18.7356/mm2) (p = 0.24). PCXL was performed safely without adverse effects, but vascular occlusion was not complete in all eyes. Conclusions: High-fluence pCXL may represent a valuable treatment option to achieve cNV regression, whilst the optimal fluence dose still remains to be defined. Anterior segment OCTA is an innovative tool for non-invasive, objective, and quantitative cNV monitoring.

Risk assessment of clinical trial protocols: a tool for hospital pharmacists to reduce human error in experimental drug management.

BACKGROUND AND OBJECTIVES: Hospital pharmacists collaborate in clinical trials by managing the reception, conservation, distribution, return and destruction of the investigational medical products (IMP). However, errors can happen during the simultaneous management of multiple trials because each clinical trial stipulates its own method for managing the drug under study. In order to promote optimal management by hospital pharmacists, we developed a method for calculating a risk of error index for each experimental protocol, and wrote standard procedures for managing trials assigned low, moderate and high risk levels, to provide hospital pharmacists with a systematic tool for reducing human error in the management of IMPs for multiple clinical trials. METHODS: Calculation of this risk of error index (ρ) entails four factors: the pharmacological risk of error (φ) inherent in the pharmacological characteristics and route of administration of the IMP (carcinogenic, mutagenic, cytotoxic nature of the drug, parental or non-parenteral administration), the technological risk of error (α) involved should drug compounding be required, the risk of error related to the number of patients enrolled (np) and the risk of error intrinsic to the protocol (π) when it involves placebos, randomisation or other factors. We developed the formula [Formula: see text] to define trials as low (ρ<50), moderate (51<ρ<150) and high risk (ρ>151) for hospital pharmacist error. RESULTS: Calculations of this formula for 60 active trials indicated that seven (11.7%) of the protocols were low risk of hospital pharmacist error, 43 (71.7%) were moderate risk and 10 (16.6%) were high risk. For each of these categories (low, moderate and high risk) we have outlined standard procedures in order to minimise the occurrence of any errors. CONCLUSIONS: Following validation of our formula and standard procedures by the ISMETT Research Institute, we are promoting the use of the tool in other clinical centres as we believe it can help hospital pharmacists minimise the risk of error in managing experimental drugs for clinical trials.

Case of tracheal rupture after endotracheal intubation: clinical risk management and medico-legal considerations.

Background: Tracheal injury may be a rare complication of the endotracheal intubation procedure. Incidence and determinant factors are not well known, nevertheless a greater incidence have been recognized with a difficult maneuver or the use of nitrogen peroxide. The therapeutic approach can be conservative or surgical, depending on the characteristics of the lesion and of the patient and therefore the outcomes of medico-legal interest can be different. Case description: It is a case of alleged medical liability regarding a 70-year-old woman, that during the intubation procedure was pouncing on the right. Furthermore, nitrous oxide was used as an anaesthetic. A few hours after the operation the patient showed swelling on the right half of the face and on the right lateral region of the neck. The emergency chest CT scan highlighted subcutaneous emphysema and pneumomediastinum. In the operating room, fibrobronchoscopy was performed with a double-lumen bronchial tube which confirmed the hypotheses lesion; then, right posterolateral thoracotomy was perfor-med followed by suturing of the tracheal lesion. Subsequently, the patient was discharged in good clinical conditions but with a scar in the region of the right hemithorax. Conclusions: Iatrogenic tracheal injury is a rare and fearful complication of the orotracheal intubation procedure. Although risk factors that increase the probability of its onset have been recognized, in most cases it is not possible to identify the cause. From a medico-legal point of view, tracheal injury after intubation is unpredictable and inevitable, so in the case reported it was decided to proceed with a conciliatory solution.

Acceptability of data linkage to identify women at risk of postnatal complication for the development of digital risk prediction tools and interventions to better optimise postnatal care, a qualitative descriptive study design.

BACKGROUND: Pregnancy acts as a cardiovascular stress test. Although many complications resolve following birth, women with hypertensive disorder of pregnancy have an increased risk of developing cardiovascular disease (CVD) long-term. Monitoring postnatal health can reduce this risk but requires better methods to identity high-risk women for timely interventions. METHODS: Employing a qualitative descriptive study design, focus groups and/or interviews were conducted, separately engaging public contributors and clinical professionals. Diverse participants were recruited through social media convenience sampling. Semi-structured, facilitator-led discussions explored perspectives of current postnatal assessment and attitudes towards linking patient electronic healthcare data to develop digital tools for identifying postpartum women at risk of CVD. Participant perspectives were gathered using post-it notes or a facilitator scribe and analysed thematically. RESULTS: From 27 public and seven clinical contributors, five themes regarding postnatal check expectations versus reality were developed, including 'limited resources', 'low maternal health priority', 'lack of knowledge', 'ineffective systems' and 'new mum syndrome'. Despite some concerns, all supported data linkage to identify women postnatally, targeting intervention to those at greater risk of CVD. Participants outlined potential benefits of digitalisation and risk prediction, highlighting design and communication needs for diverse communities. CONCLUSIONS: Current health system constraints in England contribute to suboptimal postnatal care. Integrating data linkage and improving education on data and digital tools for maternal healthcare shows promise for enhanced monitoring and improved future health. Recognised for streamlining processes and risk prediction, digital tools may enable more person-centred care plans, addressing the gaps in current postnatal care practice.

A multifaceted risk management program to improve the reporting rate of patient safety incidents in primary care: a cluster-randomised controlled trial.

BACKGROUND: While patient safety incident reporting is of key importance for patient safety in primary care, the reporting rate by healthcare professionals remains low. This study aimed to assess the effectiveness of a risk management program in increasing the reporting rate within multiprofessional primary care facilities. METHODS: A nation-wide cluster-randomised controlled trial was performed in France, with each cluster defined as a primary care facility. The intervention included professional e-learning training, identification of a risk management advisor, and multidisciplinary meetings to address incident analysis. In the first observational period, a patient safety incident reporting system for professionals was implemented in all facilities. Then, facilities were randomised, and the program was implemented. Incidents were reported over the 15-month study period. Quasi-Poisson models were used to compare reporting rates. RESULTS: Thirty-five facilities (intervention, n = 17; control, n = 18) were included, with 169 and 232 healthcare professionals, respectively, involved. Overall, 7 out of 17 facilities carried out the entire program (41.2%), while 6 did not hold meetings (35.3%); 48.5% of professionals logged on to the e-learning website. The relative rate of incidents reported was 2.7 (95% CI = [0.84-11.0]; p = 0.12). However, a statistically significant decrease in the incident rate between the pre-intervention and post-intervention periods was observed for the control arm (HR = 0.2; 95% CI = [0.05-0.54]; p = 0.02), but not for the intervention arm (HR = 0.54; 95% CI = [0.2-1.54]; p = 0.23). CONCLUSION: This program didn't lead to a significant improvement in the patient safety incident reporting rate by professionals but seemed to sustain reporting over time. Considering that the program was fully implemented in only 41% of facilities, this highlights the difficulty of implementing such multidisciplinary programs in primary care despite its adaptation to the setting. A better understanding of how risk management is currently organized in these multiprofessional facilities is of key importance to improve patient safety in primary care. TRIAL REGISTRATIONS: The study has been registered at clinicaltrials.gov (NCT02403388) on 30 March 2015.

Motivating parents to protect their children from wildfire smoke: the impact of air quality index infographics.

Background. Wildfire smoke events are increasing in frequency and intensity due to climate change. Children are especially vulnerable to health effects even at moderate smoke levels. However, it is unclear how parents respond to Air Quality Indices (AQIs) frequently used by agencies to communicate air pollution health risks. Methods. In an experiment (3 × 2 × 2 factorial design), 2,100 parents were randomly assigned to view one of twelve adapted AQI infographics that varied by visual (table, line, gauge), index type (AQI [0-500], AQHI [1-11+]), and risk level (moderate, high). Participants were told to imagine encountering the infographic in a short-term exposure scenario. They reported worry about wildfire smoke, intentions to take risk-mitigating actions (e.g., air purifier use), and support for various exposure reduction policies. Subsequently, participants were told to imagine encountering the same infographic daily during a school week in a long-term exposure scenario and again reported worry, action intentions, and policy support. Results. Parents' responses significantly differentiated between risk levels that both pose a threat to children's health; worry and action intentions were much higher in the high-risk group than the moderate-risk group in both short-exposure (F = 748.68 p<.001; F = 411.59, p<.001) and long-exposure scenarios (F = 470.51, p<.001; F = 212.01, p<.001). However, in the short-exposure scenario, when shown the AQHI [1-11+] with either the line or gauge visuals, parents' action intentions were more similar between moderate- and high-risk level groups (3-way interaction, F = 6.03, p = .002). Conclusions. These results suggest some index formats such as the AQHI-rather than the AQI-may better attune parents to moderate levels of wildfire smoke being dangerous to children's health. Our research offers insights for agencies and officials seeking to improve current public education efforts during wildfire smoke events and speaks to the critical need to educate parents and help them act short-term and long-term to protect children's health.

Performance evaluation of predictive models for detecting MMR gene mutations associated with Lynch syndrome in cancer patients in a Chinese cohort in Taiwan.

Identifying Lynch syndrome significantly impacts cancer risk management, treatment, and prognosis. Validation of mutation risk predictive models for mismatch repair (MMR) genes is crucial for guiding genetic counseling and testing, particularly in the understudied Asian population. We evaluated the performance of four MMR mutation risk predictive models in a Chinese cohort of 604 patients with colorectal cancer (CRC), endometrial cancer (EC), or ovarian cancer (OC) in Taiwan. All patients underwent germline genetic testing and 36 (6.0%) carried a mutation in the MMR genes (MLH1, MSH2, MSH6, and PMS2). All models demonstrated good performance, with area under the receiver operating characteristic curves comparable to Western cohorts: PREMM5 0.80 (95% confidence interval [CI], 0.73-0.88), MMRPro 0.88 (95% CI, 0.82-0.94), MMRPredict 0.82 (95% CI, 0.74-0.90), and Myriad 0.76 (95% CI, 0.67-0.84). Notably, MMRPro exhibited exceptional performance across all subgroups regardless of family history (FH+ 0.88, FH- 0.83), cancer type (CRC 0.84, EC 0.85, OC 1.00), or sex (male 0.83, female 0.90). PREMM5 and MMRPredict had good accuracy in the FH+ subgroup (0.85 and 0.82, respectively) and in CRC patients (0.76 and 0.82, respectively). Using the ratio of observed and predicted mutation rates, MMRPro and PREMM5 had good overall fit, while MMRPredict and Myriad overestimated mutation rates. Risk threshold settings in different models led to different positive predictive values. We suggest a lower threshold (5%) for recommending genetic testing when using MMRPro, and a higher threshold (20%) when using PREMM5 and MMRPredict. Our findings have important implications for personalized mutation risk assessment and counseling on genetic testing.

Use of a risk-based intervention bundle to prescribe and implement interventions to prevent pressure injury: An observational study.

AIM: To explore the relationship between the prescription and implementation of pressure injury preventative interventions following risk assessment combined with a risk-stratified intervention bundle. DESIGN: Single-centre, cross-sectional, observational, prospective. METHODS: The charts and bedsides of 341 adult inpatients were examined. Data collection included pressure injury risk level, prescribed preventative interventions and evidence of intervention implementation. RESULTS: Most patients (68.6%) were at risk of pressure injury, and most interventions were prescribed according to their risk level. However, evidence from direct observation and/or documentation indicated intervention implementation rates were relatively poor. Of nine interventions mandated for all patients, compliance with three patient-/carer-focused interventions was particularly poor, with evidence indicating they had been implemented for 3%-10% of patients. Also, nutritional screening-related interventions were implemented poorly. Clinically indicated implementation of heel-elevation devices and bariatric equipment was low for at-risk patients, and the implementation of interventions for patients with existing pressure injuries was suboptimal. Significant proportions of several interventions that were observed as having been implemented were not documented as such. CONCLUSION: While most interventions were prescribed according to patient risk level, the overall implementation of interventions was poor. However, the results may in part be due to failure to document interventions as opposed to omitting them. IMPLICATIONS FOR PATIENT CARE: Documentation of interventions is crucial as it provides evidence of the care provided. An increased focus on documentation of pressure injury preventative interventions is required, with a clear distinction between prescription and implementation. IMPACT: The results highlighted several deficiencies in care, particularly relating to evidence of implementation, patient involvement and nutritional screening. The results from this study will be used to inform and improve future pressure injury prevention practice within the study hospital and should be used to inform and benchmark pressure injury preventative practices in other hospitals. REPORTING METHOD: The study adheres to STROBE guidelines. PATIENT OR PUBLIC CONTRIBUTION: None.

Predicting postacute phase anaemia after aneurysmal subarachnoid haemorrhage: nomogram development and validation.

BACKGROUND: Anaemia is a severe and common complication in patients with aneurysmal subarachnoid haemorrhage (aSAH). Early intervention for at-risk patients before anaemia occurs is indicated as potentially beneficial, but no validated method synthesises patients' complicated clinical features into an instrument. The purpose of the current study was to develop and externally validate a nomogram that predicted postacute phase anaemia after aSAH. METHODS: We developed a novel nomogram for aSAH patients to predict postacute phase anaemia (3 days after occurrence of aSAH, prior to discharge) on the basis of demographic information, imaging, type of treatment, aneurysm features, blood tests and clinical characteristics. We designed the model from a development cohort and tested the nomogram in external and prospective validation cohorts. We included 456 aSAH patients from The First Affiliated Hospital for the development, 220 from Sanmen People's Hospital for external validation and a prospective validation cohort that included 13 patients from Hangzhou Red Cross Hospital. We assessed the performance of the nomogram via concordance statistics and evaluated the calibration of predicted anaemia outcome with observed anaemia occurrence. RESULTS: Variables included in the nomogram were age, treatment method (open surgery or endovascular therapy), baseline haemoglobin level, fasting blood glucose level, systemic inflammatory response syndrome score on admission, Glasgow Coma Scale score, aneurysm size, prothrombin time and heart rate. In the validation cohort, the model for prediction of postacute phase anaemia had a c-statistic of 0.910, with satisfactory calibration (judged by eye) for the predicted and reported anaemia outcome. Among forward-looking forecasts, our predictive model achieved an 84% success rate, which showed that it has some clinical practicability. CONCLUSIONS: The developed and validated nomogram can be used to calculate individualised anaemia risk and has the potential to serve as a practical tool for clinicians in devising improved treatment strategies for aSAH.

Vivencias y estrategias comunitarias de manejo del riesgo dentro de las prácticas chemsex: un estudio cualitativo / Community experiences and strategies of risk management within chemsex practices: a qualitative study

Resumen El auge en el estudio del uso sexualizado de drogas entre hombres gais, bisexuales u otros hombres que tienen sexo con hombres (HSH), conocido como chemsex, ha generado una multiplicidad de datos que contribuyen a su problematización en tanto cuestión de salud pública a través del vínculo con el VIH y las adicciones. El estudio de estas prácticas, desde un paradigma biomédico, se ha centrado en el riesgo y ha contribuido a su reducción como fenómeno único y cuantificable. Este estudio tiene como objetivo explorar la vivencia del riesgo en el transcurso de las prácticas, para conocer qué estrategias de manejo emplean frente a éste y de qué manera son generadas. Se realizaron entrevistas semiestructuradas a cinco practicantes de chemsex en el Área Metropolitana de Barcelona y, posteriormente se aplicó un análisis temático. Los hallazgos muestran cómo estos hombres detectan, asumen y enfrentan los riesgos presentes en estas prácticas, donde toman relevancia el tipo de relaciones que allí se dan y el círculo social del que disponen. Este estudio destaca también la creación de estrategias basadas en la experiencia y cómo la transmisión de estos saberes entre participantes facilita la toma de decisiones y el manejo del riesgo.

Abstract The rise in the study of sexualised drug use among gay, bisexual and other men who have sex with men (MSM), known as chemsex, has generated a multiplicity of data that contribute to its problematisation as a public health issue through the link with HIV and addictions. The study of these practices, from a biomedical paradigm, has focused on risk and has contributed to its reduction as a unique and quantifiable phenomenon. This study aims to explore the experience of risk in the course of the practices, to find out what management strategies they employ in the face of risk and how they are generated. Semi-structured interviews were conducted with five chemsex practitioners in the Metropolitan Area of Barcelona and, subsequently, a thematic analysis was applied. The findings show how these men detect, assume and confront the risks present in these practices, where the type of relationships that take place and the social circle available to them are relevant. This study also highlights the creation of strategies based on experience and how the transmission of this knowledge among participants facilitates decision-making and risk management.

Opportunities and challenges of mainstreaming disaster risk management in faith institutions.

The coronavirus disease 2019 (COVID-19) epidemic had created mayhem world over in the year 2020 and confirmed the need and urgency of equipping religious leaders with disaster risk management (DRM) knowledge and skills. Religious leaders are often expected to be among the first responders when disasters strike. This is especially the case in Africa where faith communities often have greater reach among the populace than the state itself. Using multifaceted methodology and purposive sampling interview analysis, this article shows that the responses of religious leaders in Africa, Zimbabwe in particular, to COVID-19 highlighted the urgency of adopting a more focussed and deliberate approach towards equipping religious leaders with DRM knowledge and skills. It further demonstrates that in some areas religious leaders responded effectively (communicating the right message, impact mitigation activities, etc.), in most other areas, they were as unprepared and in a state of paralysis as the rest of the populace. It would however, be grossly unfair to critique their response since most of them have never been exposed to the basic tenets of DRM, either in their formation or as part of life-long learning. Contribution: The article concludes by suggesting mainstreaming tragedy hazard reducing in the curricula of religious institutions for stoppage, mitigation and actual answer to current and future tragedies within communities.

Patient Safety Incidents in Operating Rooms Reported in the Past Five Years (2017-2021) in Korea.

Purpose: Patient safety incidents in the operating room require special attention because they can cause catastrophic and irreversible conditions in patients. Although patient safety incidents have different characteristics, there may be similarities and patterns of risk factors that may be common. Therefore, this study analyzed factors associated with the PSIs by analyzing data from the Korean Patient Safety Reports from 2017 to 2019. Methods: The "Patient Safety Incidents Data from 2017 to 2021" systematically collected by the Korea Institute for Healthcare Accreditation, include patient safety incident reports from medical institutions. Data on 1140 patient safety incidents in the operating room were analyzed. They included patients' gender and age, Hospital size, Incident seasons, incident time, Incident reporter, incident type, Medical department, and Incident severity. The Incident severity was analyzed by dividing it into three stages: near miss, adverse event, sentinel event, which are applied by domestic medical institutions. Results: The highest number of OR patient safety incidents were related to surgery and anesthesia. On analyzing the probability of adverse events based on near misses, the significant variables were patient gender, incident reporter, incident type, and Medical department. Additionally, the factors that were likely to precipitate sentinel events based on near misses were patient gender, incident time, reporter, and incident type. Conclusion: To prevent sentinel events in Patient safety incidents, female and during night shifts are required to pay close attention. Moreover, it is necessary to establish a patient safety reporting system in which not only all medical personnel, but also patients, generally, can actively participate in patient safety activities.

Personality Traits and Insurance Demand.

Personality traits drive people's financial decisions and hence affect their lives. Yet, we know little about the relationship between personality traits and insurance decisions. Do Risk-Taking, the Big Five and Locus of Control predict a variety of personal insurance decisions? Using a sample of 14,624 German adults with the goal of identifying associations between personality and insurance demand, we found that personality traits predict demand for various insurance types. We also found that associations may be mediated by demographic variables and may depend on the statistical modeling approach (e.g., including nonlinear relationships or examining between- and within-person effects). These findings contribute to our understanding of the role of personality in insurance demand and highlight the need for further exploration of this relationship, as our results demonstrate that personality-insurance-demand-associations depend on the examined insurance type.

A Case Study in Application of the Risk Knowledge Infinity Cycle.

The Risk Knowledge Infinity (RKI) Cycle Framework was featured as part of the ICH-sanctioned training materials supporting the recent issuance of ICH Q9(R1) Quality Risk Management To support ICH Q9(R1) understanding and adoption, this paper presents a case study on the application of the RKI Cycle, based on an underlying out-of-specification investigation. This case study provides a stepwise walk-through of the cycle to illustrate how key concepts within the ICH Q9(R1) revision can be achieved through better connecting quality risk management and knowledge management with a framework such as the RKI Cycle.