Robust Risk Assessment Research Articles

Critical gaps in nanoplastics research and their connection to risk assessment.

Reports of plastics, at higher levels than previously thought, in the water that we drink and the air that we breathe, are generating considerable interest and concern. Plastics have been recorded in almost every environment in the world with estimates on the order of trillions of microplastic pieces. Yet, this may very well be an underestimate of plastic pollution as a whole. Once microplastics (<5mm) break down in the environment, they nominally enter the nanoscale (<1,000nm), where they cannot be seen by the naked eye or even with the use of a typical laboratory microscope. Thus far, research has focused on plastics in the macro- (>25mm) and micro-size ranges, which are easier to detect and identify, leaving large knowledge gaps in our understanding of nanoplastic debris. Our ability to ask and answer questions relating to the transport, fate, and potential toxicity of these particles is disadvantaged by the detection and identification limits of current technology. Furthermore, laboratory exposures have been substantially constrained to the study of commercially available nanoplastics; i.e., polystyrene spheres, which do not adequately reflect the composition of environmental plastic debris. While a great deal of plastic-focused research has been published in recent years, the pattern of the work does not answer a number of key factors vital to calculating risk that takes into account the smallest plastic particles; namely, sources, fate and transport, exposure measures, toxicity and effects. These data are critical to inform regulatory decision making and to implement adaptive management strategies that mitigate risk to human health and the environment. This paper reviews the current state-of-the-science on nanoplastic research, highlighting areas where data are needed to establish robust risk assessments that take into account plastics pollution. Where nanoplastic-specific data are not available, suggested substitutions are indicated.

Near-wall hemodynamic parameters quantification in in vitro intracranial aneurysms with 7 T PC-MRI

ObjectiveWall shear stress (WSS) and its derived spatiotemporal parameters have proven to play a major role on intracranial aneurysms (IAs) growth and rupture. This study aims to demonstrate how ultra-high field (UHF) 7 T phase contrast magnetic resonance imaging (PC-MRI) coupled with advanced image acceleration techniques allows a highly resolved visualization of near-wall hemodynamic parameters patterns in in vitro IAs, paving the way for more robust risk assessment of their growth and rupture.Materials and methodsWe performed pulsatile flow measurements inside three in vitro models of patient-specific IAs using 7 T PC-MRI. To this end, we built an MRI-compatible test bench, which faithfully reproduced a typical physiological intracranial flow rate in the models.ResultsThe ultra-high field 7 T images revealed WSS patterns with high spatiotemporal resolution. Interestingly, the high oscillatory shear index values were found in the core of low WSS vortical structures and in flow stream intersecting regions. In contrast, maxima of WSS occurred around the impinging jet sites.ConclusionsWe showed that the elevated signal-to-noise ratio arising from 7 T PC-MRI enabled to resolve high and low WSS patterns with a high degree of detail.

Digital Technology in Cardiovascular Health: Role and Evidence Supporting Its Use.

Digital Technology in Cardiovascular Health: Role and Evidence Supporting Its Use.

Modeling Potential Glacial Lake Outburst Flood Process Chains and Effects From Artificial Lake‐Level Lowering at Gepang Gath Lake, Indian Himalaya

AbstractGlacial lake outburst floods (GLOFs) are a severe threat to communities in the Himalayas; however, GLOF mitigation strategies have been implemented for only a few lakes, and future changes in hazard are rarely considered. Here, we present a comprehensive assessment of current and future GLOF hazard for Gepang Gath Lake, Western Himalaya, considering rock and/or ice avalanches cascading into the lake. We consider ground surface temperature and topography to define avalanche source zones located in areas of potentially degrading permafrost. GLOF process chains in current and future scenarios, also considering engineered lake lowering of 10 and 30 m, were evaluated. Here, varied avalanche impact waves, erosion patterns, debris flow hydraulics, and GLOF impacts at Sissu village, under 18 different scenarios were assessed. Authors demonstrated that a larger future lake does not necessarily produce larger GLOF events in Sissu, depending, among other factors, on the location from where the triggering avalanche initiates and strikes the lake. For the largest scenarios, 10 m of lowering reduces the high‐intensity zone by 54% and 63% for the current and future scenarios, respectively, but has little effect on the medium‐intensity flood zone. Even with 30 m of lake lowering, the Sissu helipad falls in the high‐intensity zone under all moderate‐to‐large scenarios, with severe implications for evacuations and other emergency response actions. The approach can be extended to other glacial lakes to demonstrate the efficiency of lake lowering as an option for GLOF mitigation and enable a robust GLOF hazard and risk assessment.

Abstract P6-02-13: Expanding the reach of germline genetic testing: Use of web-based risk assessment to inform medical management amongst patients at breast and imaging centers

Abstract Background Developing an effective approach to the identification of individuals at increased cancer risk is key to preventing and/or providing early diagnosis of cancer. However, outside of targeted genetics clinics, under identification of individuals with hereditary cancer risk is well recognized, due in part to ever evolving complexity of germline genetic testing criteria and lack of systematic framework to perform robust risk assessment on all patients. In contrast, breast and imaging centers are ideally positioned to maximize the impact of positive genetic test results due to immediate availability of surveillance and diagnostic tools. Here we present data from breast and imaging centers using a patient-facing digital platform offered universally to all patients before their scheduled appointment designed to collect personal and family health information and assess cancer risk and genetic testing eligibility based on current guidelines. Methods We conducted a retrospective observational study of patients in breast and imaging centers who used a web-based risk stratification tool before standard ambulatory appointments to assess their lifetime risk for breast cancer based on the Tyrer-Cuzick (version 8.0) risk algorithm and eligibility for National Comprehensive Cancer Network (NCCN®) genetic testing criteria at the time of assessment. Testing criteria included hereditary breast, ovarian, pancreatic, and prostate cancers, Lynch syndrome, and familial adenomatous polyposis (FAP). Data was pulled for patients seen from June 2020 through May 2022 at participating breast and imaging centers throughout the United States. Outcome measures included percentage of individuals who completed the risk-assessment, met testing criteria, pursued germline genetic testing, received a positive germline result, and/or had a Tyrer-Cuzick breast cancer risk ≥20%. Results A total of 251,492 individuals completed assessments; 250,011 (99%) were females aged 18 years or older. Overall, at the time of assessment 80,814/251,492 (32.1%) met genetic testing criteria and 24.4% (19,694) of those meeting criteria opted to proceed with germline genetic testing. An additional 1,561 individuals who did not meet criteria pursued genetic testing. Of the 18,532 completed genetic tests, 1,507 (8.1%) had positive genetic test results. The majority of positive individuals (93%) met testing criteria. 40.7% (613/1,507) of positive results had an impact on breast cancer risk management options. In addition to individuals identified as high-risk through germline genetic testing evaluations, 13.1% (28,108/214,269) of individuals assessed using the Tyrer-Cuzick algorithm had ≥20% lifetime risk of breast cancer and met the threshold for modified medical management. Conclusion In this study, the web-based assessment tool provided a standardized workflow that enabled individuals interested in receiving cancer risk assessment and germline testing an opportunity to do so. When offered to all patients, this digital platform can offer a scalable opportunity for breast and imaging centers to identify individuals eligible for modified medical management for breast cancer risk and other inherited cancer syndromes, which may ultimately improve the prevention and early treatment of individuals with cancer predisposition. Citation Format: Heather Fecteau, Haley Keller, Carrie Horton, Carrie Milliard, Robert Pilarski, Lukas Lyon, Lily Hoang, Shannon Kieran. Expanding the reach of germline genetic testing: Use of web-based risk assessment to inform medical management amongst patients at breast and imaging centers [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-02-13.

Seismic Collapse Risk Assessment of Low-Aspect-Ratio Reinforced Concrete Shear Walls Using the FEMA P695 Methodology

Several recent research studies have demonstrated that the seismic performance of low-aspect-ratio reinforced concrete (RC) shear walls (i.e., defined herein as walls with height-to-length ratios less than 2) has not been yet adequately quantified to allow for robust risk assessment. This is mainly attributed to the complex nonlinear flexure/shear interaction behavior of such walls, along with their wide spectrum of possible design parameters, leading to major discrepancies in their seismic performance. Despite this unique behavior, most building codes and design standards do not assign distinctive seismic performance factors for such walls. To address this, the main objective of the current study is to propose seismic performance factors for low-aspect-ratio RC shear walls when different wall geometrical configurations and design parameters (e.g., aspect ratios, axial load levels, and seismic design categories) are adopted. These factors are evaluated against the acceptance criteria of the FEMA P695 methodology for Quantification of Building Seismic Performance Factors. In this respect, a numerical model was developed and experimentally validated to simulate the seismic response of 36 low-aspect-ratio RC shear wall archetypes. The model was utilized to perform nonlinear static and dynamic analyses, and collapse fragility curves were then generated to assess the collapse risk of such wall archetypes following the FEMA P695 methodology. According to the methodology, the proposed seismic performance factors were assessed by quantifying the ratio between the median collapse intensity and the intensity of the maximum considered earthquake (MCE). The results showed that R factors of 2.0 and 3.0 for special low-aspect-ratio RC walls with low and high axial load levels, respectively, can limit the probability of collapse under the MCE and are subsequently able to meet the FEMA P695 acceptance criteria.

An Integrated Approach of Threat Analysis for Autonomous Vehicles Perception System

Automated vehicles are a revolutionary step in mobility, providing a safe and convenient riding experience while keeping the human-driving task minimal to none. Therefore, these intelligent vehicles are equipped with sophisticated perception sensors (e.g., cameras and radars), high-performance computers, artificial intelligence (AI)-driven algorithms, and connectivity with other internet-of-things (IoT) devices. This makes autonomous vehicles (AVs) a special kind of cyber-physical system (CPS) that is moving at speed in highly interactive and dynamic environments (e.g., public roads). Thus, AV is a potential target for cyber attackers to weaponize, compromising safety and mobility on the road. The first step in addressing this problem is to have a robust threat modeling framework that can address the evolving cyber-physical threats, especially to AV applications. In this regard, two areas are studied in this paper: the common practice of threat modeling in automotive and the ISO/SAE 21434 standard, and sensors and machine learning (ML) algorithms for AV perception systems and potential cyber-physical attacks. A comparative threat analysis for an AV perception system with the ISO/SAE 21434 standard and a system-theoretic process analysis for security (STPA-Sec) approach is also demonstrated in this paper. Based on the analysis, this paper proposes a robust threat analysis and risk assessment framework with mathematical modeling to identify cyber-physical threats to AV perception systems that are critical for the driving behaviors and complex interactions of AVs in their operational design domain.

The Role of Social Systems Failure Risks and Control in the Digitization of Banking: A Case Study of Banking Failure in Ireland

The digitization of banking has brought about significant advancements in the financial sector. However, as with any technology, digitized banking systems are not without risks. This paper examines the role of social systems failure risks and control in the digitization of banking using a case study of a banking failure in Ireland. Drawing on interviews and testimonials from a national parliamentary inquiry and analysis of relevant documents, the study identifies the social systems failure risks and control mechanisms that were in place prior and during the banking failure. The findings reveal that social systems failure risks, such as a lack of communications, insufficient training, and inadequate risk management, played a significant role in the banking failure. Moreover, the study highlights the importance of effective control mechanisms, such as robust risk assessment procedures and strong governance structures, in mitigating these risks.

Evaluation of the risk of pollution caused by ship operations through bow-tie-based fuzzy Bayesian network

Ocean and marine environments face the adverse effects of climate change and environmental pollution. Maritime transportation, one of the most severe marine pollution sources because of ship-sourced operations, poses risks to the marine environment in many types and ways. A robust risk assessment should be organised to identify causal mechanisms and the resources of the pollution. In this study, the steps of ship operations that may cause marine pollution and the structure of the relations between them were established based on their expert opinions and the information contained in the literature. On this basis, the probabilities of each ship's operations that cause marine pollution are computed by the Fuzzy Bayesian Network approach. The extent of the response operation according to the level of marine pollution is determined by the Bow-tie approach. As a result, the procedures that cause funnel gas emissions are the riskiest. The study will be beneficial for the practitioners of safety and environmental management in maritime transportation to make decisions practically and strategically.

Profiling of cell-free DNA methylation and histone signatures in pediatric NAFLD: A pilot study.

Nonalcoholic fatty liver disease (NAFLD) has become the most common chronic liver disease in children and adolescents, increasing the risk of its progression toward nonalcoholic steatohepatitis (NASH), cirrhosis, and cancer. There is an urgent need for noninvasive early diagnostic and prognostic tools such as epigenetic marks (epimarks), which would replace liver biopsy in the future. We used plasma samples from 67 children with biopsy-proven NAFLD, and as controls we used samples from 20 children negative for steatosis by ultrasound. All patients were genotyped for patatin-like phospholipase domain containing 3 (PNPLA3), transmembrane 6 superfamily member 2 (TM6SF2), membrane bound O-acyltransferase domain containing 7 (MBOAT7), and klotho-β (KLB) gene variants, and data on anthropometric and biochemical parameters were collected. Furthermore, plasma cell-free DNA (cfDNA) methylation was quantified using a commercially available kit, and ImageStream(X) was used for the detection of free circulating histone complexes and variants. We found a significant enrichment of the levels of histone macroH2A1.2 in the plasma of children with NAFLD compared to controls, and a strong correlation between cfDNA methylation levels and NASH. Receiver operating characteristic curve analysis demonstrated that combination of cfDNA methylation, PNPLA3 rs738409 variant, coupled with either high-density lipoprotein cholesterol or alanine aminotransferase levels can strongly predict the progression of pediatric NAFLD to NASH with area under the curve >0.87. Conclusion: Our pilot study combined epimarks and genetic and metabolic markers for a robust risk assessment of NAFLD development and progression in children, offering a promising noninvasive tool for the consistent diagnosis and prognosis of pediatric NAFLD. Further studies are necessary to identify their pathogenic origin and function.

Investigation of the Influence of Grain-Scale Heterogeneity on Strainburst Proneness Using Rock-Like Material

As mining and tunnelling projects advance to deeper areas, strainbursts occur more frequently. This failure mode is extremely dangerous, as the rock mass fails abruptly, releasing high amounts of energy. This poses a high risk to the life of workers and equipment used. For a robust strainburst risk assessment many factors have to be taken into account. Besides geological features, overburden, excavation method, etc., rocks’ intrinsic proneness to strainburst plays a major role. Whether a rock tends to this failure behaviour depends strongly on the rocks’ mechanical and structural characteristics at the grain-level, especially on its heterogeneity. The authors demonstrate this based on different rock-like sample sets, consisting of a very fine-grained fibreless ultra-high-performance concrete (UHPC) and a constant volumetric fraction of coarse aggregates. Thereby, the heterogeneity aspect was introduced by the different properties of the aggregates. A laboratory program was performed, taking into account uniaxial compression tests (including post-failure tests to evaluate the failure energy) and Acoustic Emission Testing (to monitor the cracking activity). The study underlines the high suitability of using Acoustic Emission Testing (AET) in strainburst risk assessment. In addition, the authors analyse empirical parameters commonly used to evaluate rocks’ intrinsic proneness to strainburst, and give recommendations regarding their application. Overall, the study substantiates former research and emphasises the usefulness of petrographic information within strainburst risk analysis. It also sets the base for future research on real rock, which will hopefully lead to more specific recommendations for practitioners on how to include rocks’ grain-scale characteristics in strainburst risk analysis.

The Path to UVCBEcological Risk Assessment: Grappling with Substance Characterization.

Substances of unknown or variable composition, complex reaction products, and biological materials (UVCBs) pose a unique challenge to regulators and to product registrants, who are required to characterize their fate, exposure, hazard, and potential risks to human health and the environment. To address these challenges and ensure an efficient and fit-for-purpose process, it is proposed that the ecological risks of UVCBs be assessed following a tiered strategy. The development of this approach required exploring how substance composition ties into hazard and exposure information and determining the extent to which a UVCB needs to be characterized to ensure a robust risk assessment. The present study highlights the key aspects of this new method. It presents how a tiered substance characterization approach can be integrated into broader UVCB risk-assessment schemes to encourage an examination of data needs before a full substance characterization is performed. The first tier of the characterization process, Tier 0, is a fundamental step that includes data from basic, lower-resolution compositional analyses. Tier 0 assessments can be used to inform hazard and exposure for any substance of interest. The need for more sophisticated, higher-tier characterization is determined by the level of uncertainty of the risk assessment. The next step will integrate a tiered exposure assessment into the characterization scheme featured in the present study, to create a more complete risk-assessment framework. Environ Toxicol Chem 2022;41:2649-2657. © 2022 Her Majesty the Queen in Right of Canada, Health and Environmental Sciences Institute and The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC. Reproduced with the permission of the Minister of Environment and Climate Change Canada.

Reliable, robust, and comprehensive risk assessment framework for urban autonomous driving

Abstract Urban autonomous driving is both complex and dangerous. A multitude of road types, road users, and potential traffic rule violations all make it challenging for an autonomous vehicle to safely navigate an urban environment. To tackle this issue, in this paper, we propose a risk assessment framework capable of reliably predicting and assessing the possibility of collision in urban environments involving the concurrent occurrence of various road types, road users, and traffic rule violations. The proposed framework reliably predicts and assesses the possibility of collision by means of long-term motion prediction–based risk identification, unified risk measures, and probabilistic risk reasoning under a distributed reasoning architecture. The framework is tested and evaluated through real-world testing conducted not only on private urban test roads under a great variety of driving scenarios but also on public urban roads under real traffic conditions. Experimental results show the performance of the framework to be sufficiently reliable for urban autonomous driving in terms of risk assessment.

A stakeholder-based taxonomy for managing regulatory compliance risk and aligning to business strategy

Despite advances in how organisations identify and categorise evolving regulatory requirements, there is no common alignment around a robust taxonomy to manage regulatory compliance risk. This paper explains the importance of risk taxonomy, and how objectives provide the lens through which to categorise risks in a robust taxonomy. It summarises a stakeholder-based approach for categorising regulatory compliance risk, providing a financial services taxonomy example that has been successfully implemented at CWB. The advantages of a stakeholder-based taxonomy approach are reviewed, including its (a) robust risk identification and assessment; (b) flexible application to any scale or complexity of enterprise; (c) natural alignment for structuring oversight; (d) facilitation of focused reporting and aggregated updates; (e) agility to apply to an evolving external landscape; and most importantly (f) alignment with processes and tools for strategic management. Areas for further research to expand that literature are proposed, building from the paper's two main ideas — applying an objectives focus to risk taxonomy, and using it to apply a stakeholder-based approach to regulatory compliance risk taxonomy. The paper concludes with practical next step considerations for chief compliance officers in managing their own programmes.

Information entropy tradeoffs for efficient uncertainty reduction in estimates of air pollution mortality

Implementing effective policy to protect human health from the adverse effects of air pollution, such as premature mortality, requires reducing the uncertainty in health outcomes models. Here we present a novel method to reduce mortality uncertainty by increasing the amount of input data of air pollution and health outcomes, and then quantifying tradeoffs associated with the different data gained. We first present a study of long-term mortality from fine particulate matter (PM2.5) based on simulated data, followed by a real-world application of short-term PM2.5-related mortality in an urban area. We employ information yield curves to identify which variables more effectively reduce mortality uncertainty when increasing information. Our methodology can be used to explore how specific pollution scenarios will impact mortality and thus improve decision-making. The proposed framework is general and can be applied to any real case-scenario where knowledge in pollution, demographics, or health outcomes can be augmented through data acquisition or model improvements to generate more robust risk assessments.

Numerical Simulations of a Postulated Methanol Pool Fire Scenario in a Ventilated Enclosure Using a Coupled FVM-FEM Approach

Numerical investigations have been carried out for a postulated enclosure fire scenario instigated due to methanol pool ignition in a chemical cleaning facility. The pool fire under consideration is radiation-dominated and poses a risk to the nearby objects if appropriate safety requirements are not met. The objective of the current study was to numerically evaluate the postulated fire scenario and provide safety recommendations to prevent/minimize the hazard. To do this, the fire scenario was first modeled using the finite volume method (FVM) based solver to predict the fire characteristics and the resulting changes inside the enclosure. The FDS predicted temperatures were then used as input boundary conditions to conduct a three-dimensional heat transfer analysis using the finite element method (FEM). The coupled FVM–FEM simulation approach enabled detailed three-dimensional conjugate heat transfer analysis. The proposed FVM–FEM coupled approach to analyze the fire dynamics and heat transfer will be helpful to safety engineers in carrying out a more robust and reliable fire risk assessment.

Ensuring robust radiological risk assessment for wildlife: insights from the International Atomic Energy Agency EMRAS and MODARIA programmes

In response to changing international recommendations and national requirements, a number of assessment approaches, and associated tools and models, have been developed over the last circa 20 years to assess radiological risk to wildlife. In this paper, we summarise international intercomparison exercises and scenario applications of available radiological assessment models for wildlife to aid future model users and those such as regulators who interpret assessments. Through our studies, we have assessed the fitness for purpose of various models and tools, identified the major sources of uncertainty and made recommendations on how the models and tools can best be applied to suit the purposes of an assessment. We conclude that the commonly used tiered or graded assessment tools are generally fit for purpose for conducting screening-level assessments of radiological impacts to wildlife. Radiological protection of the environment (or wildlife) is still a relatively new development within the overall system of radiation protection and environmental assessment approaches are continuing to develop. Given that some new/developing approaches differ considerably from the more established models/tools and there is an increasing international interest in developing approaches that support the effective regulation of multiple stressors (including radiation), we recommend the continuation of coordinated international programmes for model development, intercomparison and scenario testing.

Skin Cancer Knowledge, Attitudes and Sun Protection Practices in the Hispanic Population: A Cross-Sectional Survey.

Hispanics are more likely to be diagnosed with skin cancer at a later stage and experience worse overall survival than Whites. The objective of this cross-sectional study was to assess the skin cancer knowledge, attitudes, perceived risk, and sun protection practices among an underserved population in the Phoenix area. We recruited participants from the greater Phoenix area to undergo skin examination and complete a questionnaire. 208 participants were included. The majority were Hispanic (64.9%). Of this Hispanic group, most were from Mexico (87.9%). The Hispanic cohort had an overall mean skin cancer knowledge score of 3.68/6, the lowest of any other racial/ethnic group, but had the highest desire to learn more about skin cancer (64.6%, "strongly agree"). They were the most concerned about developing skin cancer (50.4%, "very concerned") but had relatively lower rates of sun protection practices (7.9% "always use" sunscreen, 22.0% "always use" sun-protective clothing). Limitations of this study include a small sample size, lack of validation for the skin cancer knowledge score, lack of season as a covariate in the multivariate analysis, lack of follow-up, and lack of robust skin cancer risk assessment. In conclusion, despite poorer skin cancer knowledge and sun protection practices, the Hispanic population had the highest concern for developing skin cancer and desire to learn more about skin cancer. Targeted and culturally relevant skin cancer and sun protection education for this group is needed.

Developing a New Suicide Risk Assessment for Virtual Encounters with Non-Clinicians

IntroductionThe COVID-19 pandemic has necessitated that many research encounters be conducted virtually. Non clinician staff (e.g. research assistants (RAs), study coordinators, or research trainees) with varying levels of clinical training and experience are typically the primary point of contact for research participants. Consequently, they are often the first to encounter suicidality. This highlights the need for robust virtual suicide risk assessment procedures that are at an appropriate level for research staff and optimized for remote clinical research visits. The current procedures for in-person visits conducted by the Geriatric Psychiatry Program at McLean Hospital require non-clinician staff to complete the full Columbia Suicide Severity Rating Scale (CSSRS) in situations of active suicidal ideation (SI) before requiring clinician notification and intervention. However, staff and clinicians both reported that the virtual visit format limited the quality of the assessment and the ability to respond rapidly in situations of passive suicidal ideation, especially when this ideation did not meet the threshold for clinician notification specified in the in-person protocol. Thus, we established the need for a specific virtual suicide risk assessment protocol. Here we present our process for needs assessment and its findings, which in turn have shaped our revised protocol.MethodsWe surveyed clinicians and social workers affiliated with the Geriatric Psychiatry Research Program at McLean Hospital. The first goal of this survey was to collect information on how clinicians respond to situations of suicidality during telehealth assessments, and how clinicians recommend that staff navigate these situations in a virtual research setting. The second goal was to gather qualitative data that would guide preparatory safety planning (PSP) that non-clinician staff could complete prior to research visits. Because there are no standardized instruments for the information we wanted to collect, we developed a survey based on consensus among research staff.ResultsOf the 19 clinicians surveyed, 11 completed the brief survey. Nine (81.8%) of the eleven clinicians that responded had needed to deal with a patient at imminent risk of suicide in any setting. Only three (27.27%) clinicians were fully comfortable using the in-person SI protocol for virtual encounters. All 11 (100%) of responding clinicians conveyed that PSP should include information on (a) the exact location of the patient's home, (b) contact information for friends and family, and (c) an assessment of firearm access. The PSP should be completed as early as feasible in the research process, prior to formal enrollment, even if there was no reason to suspect SI at the time. Additional qualitative feedback included recommendations for lowering the threshold for enacting the SOP from subjects expressing active SI to passive SI to facilitate earlier intervention. Clinicians also recommended training staff on formal assessment measures such as the combined SAFE-T (Suicide Assessment Five-step Evaluation and Triage) and CSSRS protocol in a structured interview so that they could conduct a more systematic assessment if passive SI was reported.ConclusionsAs more research encounters are conducted virtually, protocols designed for in-person assessment of suicide risk must be adapted. We found that the most useful addition to a virtual SI protocol may be to lower the threshold for action from active to passive SI and inclusion of PSP. Our findings also indicate that staff should be trained in standardized suicide assessment and that there should be a low threshold for conducting these assessments (i.e. passive ideation) and notifying clinicians. Our findings may be broadly generalizable to all mental health research settings that involve virtual assessment by non-clinician staff.This research was funded byThis work was supported in part by an unrestricted philanthropic gift from Eric Warren Goldman to the Technology and Aging Lab at McLean Hospital

IQbD: A Technological Readiness Level-Indexed Quality-by-Design Paradigm for Medical Device Engineering

Abstract Risk assessment is a critical step in the roadmap of medical device development (MDD). Failure modes, effects and criticality analysis is a common approach based on declarative prior information that proved beneficial in the risk assessment of well-established processes. But at early steps of development when innovative materials or technologies are embedded, the lack of experience on those innovations introduces too much subjectivity in failure modes, effects, and criticality analysis (FMECA) for a robust risk assessment. Since mid-2000, the quality-by-design (QbD) guideline has been proposed within the pharmaceutical industry as a pro-active engineering approach to drug development. This paradigm enables a data-driven risk assessment throughout the development workflow, which completes the risk assessment provided by FMECA. Nevertheless, its implementation guide is unclear and not flexible enough to be efficiently applied to the development of medical devices. To address this issue, a new quality by design (QbD) paradigm indexed on the technological readiness level of the innovative product is proposed. It covers the development of medical devices throughout the whole preclinical phase and is composed of at least nine learning cycles. The first part of this medical device QbD layout, composed of three consecutive risk assessment cycles, is evaluated through a real study case with the objective to demonstrate the proof of concept of a photobleaching controller in photodynamic therapy. Beyond this experimental result, this application has confirmed practical ability of the indexed quality by design (iQbD) approach to complete FMECA and to provide an alternative solution to risk assessment when prior knowledge on the technological innovation is not available.