HAZMAT Technician-level Emergency Response: A Mental Model Framework for Radiological Dispersal Device (RDD) Incidents.

ABSTRACT: This research examines the cognitive frameworks used by HAZMAT technicians when responding to incidents involving Radiological Dispersal Devices (RDDs), which are conventional explosive devices with radioactive materials incorporated. The objective is to introduce the Expected Mental Model State (EMMS) as a comprehensive evaluation tool for assessing and enhancing the expertise and situational awareness of emergency responders dealing with radiation crises. Through a series of expert focus group sessions using the well-established qualitative methodology of grounded theory, an Expected Mental Model State (EMMS) was developed. The methodology used an influence diagram architecture to conceptually capture and codify key areas relevant to effective emergency response. The research identifies fourteen EMMS key conceptual domains, further elaborated into 301 subtopics, providing a multi-dimensional structure for the proposed mental model framework. Three pivotal notions of mental model emerged within the EMMS framework: Knowledge Topology, Envisioning (Belief), and Response and Operability. These notions were found to align with previous theories of mental models and are vital for understanding how HAZMAT technicians conceptualize and respond to RDD incidents. The study emphasizes the critical role of mental models in enhancing preparedness and effective response strategies during radiation emergencies. The EMMS framework offers a versatile methodology that can be adapted across various kinds of emergency responders and high-risk situations, including the broader Chemical, Biological, Radiological, and Nuclear (CBRN) spectrum. Using this EMMS framework to develop an EMMS Diagnostic Matrix can provide a roadmap for identifying areas for the development of specialized training modules that have the potential to significantly elevate both the quality and efficacy of responder training and preparation.

Using Non-immersive VR Simulations in Conjunction with Priming to Enhance Conceptualizing Radiation and Risk.

Radiation is present daily and used throughout many industries for beneficial purposes. Safety professionals and workers need a general understanding of radiation identification techniques and associated risks to manage the work environment with radiation protection practices. This is especially important in workplaces where the radiation source is ancillary to the primary activities of the industry. The elusive nature of radiation makes learners understanding in an educational setting a challenge. Furthermore, delivering a hands-on experience to support learning and training of radiation, its assessment, and protection measures is quite difficult, given its hazardous nature. Virtual reality, even using non-immersive environments, offers significant benefits through simulating sources of radiation. A non-immersive simulator titled AssessRadVR, facilitated the radiation experience and presented dynamically the effects of the trainees' interactions with shielding materials, detection equipment, and the working environment. Yet, interaction with simulation alone may not trigger effective encoding of these critical aspects in long-term memory. This paper discusses using the AssessRadVR simulator in conjunction with a procedure for subliminally priming the long-term memory encoding to enhance radiation's activated representation. Students in an introductory industrial hygiene class were divided into two groups and primed with either alarming or non-alarming words following the Bargh, Chen, & Borrows procedure (1996). Results demonstrated that students primed with alarming words were more open to objectively evaluating the radiation sources due to their overall perception that the risk was manageable. Why is this of interest to the community: The results provided that even with limited prior knowledge in radiation, after engaging with the simulator, most students were able to recognize and apply radiation principles, which indicates they could apply key principles in a real-world radiation workplace. Further, the impact of activating with alarming words led to a statistically significantly higher perception that working in the radiation environment was manageable.

Compensatory Considerations for Radiological Emergency Response and Public Protective Actions during the COVID-19 Pandemic.

ABSTRACT: Epidemiological evidence and models have demonstrated that the current COVID-19 pandemic introduces a significant public risk to implementing large-scale community evacuations in response to disasters. While guidance documented in the US Environmental Protection Agency Protective Action Guidance (PAG) Manual is widely accepted as the standard basis for public and emergency worker protective actions for a radiological emergency, it is based primarily on assessing the risks associated with the radiological factors alone. However, as demonstrated in response to the nuclear incident in Fukushima, these events seldom occur in isolation from other risk-inducing events. Today, the COVID-19 pandemic represents a significant public health risk that must also be considered alongside the radiation risks in determining appropriate public and emergency worker protection action decisions. In particular, the significant public health risks associated with community transmission and mortality of COVID-19 challenge our most familiar and rehearsed radiological response strategies. The 1992 and 2017 US Environmental Protection Agency PAG manuals allow for considerations in protective action decision making. Much of the radiation emergency response community has been conditioned through decades of structured training and exercises to focus public protection considerations on specific guidelines referenced numerically in tables within the manual. Discussion regarding adjustment of specific PAG values is provided in the footnotes and bases portions of the PAG manual but is often not included in jurisdictional plans or routinely considered in exercises. However, when properly applied, the protective action guidance provides the necessary flexibility for decision-makers to account for additional public health risks or impediments, and jurisdictions can use this guidance to build a more effective response strategy. The authors have applied the full guidance and flexibility provided in the 2017 US Environmental Protection Agency PAG Manual to develop more specific guidance for their respective jurisdictions' radiation emergency response plans and will outline a process for consideration of protective action decisions to maximize the protection of public health and safety.

Disrupted circadian clocks and altered tissue mechanics in primary human breast tumours.

BACKGROUND: Circadian rhythms maintain tissue homeostasis during the 24-h day-night cycle. Cell-autonomous circadian clocks play fundamental roles in cell division, DNA damage responses and metabolism. Circadian disruptions have been proposed as a contributing factor for cancer initiation and progression, although definitive evidence for altered molecular circadian clocks in cancer is still lacking. In this study, we looked at circadian clocks in breast cancer. METHODS: We isolated primary tumours and normal tissues from the same individuals who had developed breast cancer with no metastases. We assessed circadian clocks within primary cells of the patients by lentiviral expression of circadian reporters, and the levels of clock genes in tissues by qPCR. We histologically examined collagen organisation within the normal and tumour tissue areas, and probed the stiffness of the stroma adjacent to normal and tumour epithelium using atomic force microscopy. RESULTS: Epithelial ducts were disorganised within the tumour areas. Circadian clocks were altered in cultured tumour cells. Tumour regions were surrounded by stroma with an altered collagen organisation and increased stiffness. Levels of Bmal1 messenger RNA (mRNA) were significantly altered in the tumours in comparison to normal epithelia. CONCLUSION: Circadian rhythms are suppressed in breast tumour epithelia in comparison to the normal epithelia in paired patient samples. This correlates with increased tissue stiffness around the tumour region. We suggest possible involvement of altered circadian clocks in the development and progression of breast cancer.

Increased peri-ductal collagen micro-organization may contribute to raised mammographic density.

BACKGROUND: High mammographic density is a therapeutically modifiable risk factor for breast cancer. Although mammographic density is correlated with the relative abundance of collagen-rich fibroglandular tissue, the causative mechanisms, associated structural remodelling and mechanical consequences remain poorly defined. In this study we have developed a new collaborative bedside-to-bench workflow to determine the relationship between mammographic density, collagen abundance and alignment, tissue stiffness and the expression of extracellular matrix organising proteins. METHODS: Mammographic density was assessed in 22 post-menopausal women (aged 54-66 y). A radiologist and a pathologist identified and excised regions of elevated non-cancerous X-ray density prior to laboratory characterization. Collagen abundance was determined by both Masson's trichrome and Picrosirius red staining (which enhances collagen birefringence when viewed under polarised light). The structural specificity of these collagen visualisation methods was determined by comparing the relative birefringence and ultrastructure (visualised by atomic force microscopy) of unaligned collagen I fibrils in reconstituted gels with the highly aligned collagen fibrils in rat tail tendon. Localised collagen fibril organisation and stiffness was also evaluated in tissue sections by atomic force microscopy/spectroscopy and the abundance of key extracellular proteins was assessed using mass spectrometry. RESULTS: Mammographic density was positively correlated with the abundance of aligned periductal fibrils rather than with the abundance of amorphous collagen. Compared with matched tissue resected from the breasts of low mammographic density patients, the highly birefringent tissue in mammographically dense breasts was both significantly stiffer and characterised by large (>80 µm long) fibrillar collagen bundles. Subsequent proteomic analyses not only confirmed the absence of collagen fibrosis in high mammographic density tissue, but additionally identified the up-regulation of periostin and collagen XVI (regulators of collagen fibril structure and architecture) as potential mediators of localised mechanical stiffness. CONCLUSIONS: These preliminary data suggest that remodelling, and hence stiffening, of the existing stromal collagen microarchitecture promotes high mammographic density within the breast. In turn, this aberrant mechanical environment may trigger neoplasia-associated mechanotransduction pathways within the epithelial cell population.

Informed consent conversations and documents: A quantitative comparison.

BACKGROUND: Informed consent for clinical research includes 2 components: informed consent documents (ICDs) and informed consent conversations (ICCs). Readability software has been used to help simplify the language of the ICD, but to the authors' knowledge is rarely used to assess the language used during the ICC, which may influence the quality of informed consent. The current analysis was performed to determine whether length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected the use of simpler language and comprehensiveness. METHODS: The current study was a prospective study in which ICCs were audiorecorded at 6 institutions when families were offered participation in pediatric phase I oncology trials. Word count, Flesch-Kincaid Grade Level (FKGL), and Flesch Reading Ease score (FRES) of the ICCs were compared with corresponding ICDs, including the frequency with which investigators addressed 8 prespecified critical consent elements during the ICC. RESULTS: Sixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4677 vs 6364 words; P = .0016) and had a lower FKGL (6 vs 9.7; P ≤ .0001) and a higher FRES (77.8 vs 56.7; P<.0001) compared with their respective ICDs, but were more likely to omit critical consent elements, such as voluntariness (55%) and dose-limiting toxicities (26%). Years of investigator experience was not correlated with reliably covering critical elements or decreased linguistic complexity. CONCLUSIONS: Clinicians use more understandable language during ICCs than the corresponding ICD, but appear to less reliably cover elements critical to fully informed consent. Efforts focused at providing communication training for clinician-investigators should be made to optimize the synergy between the ICD and the ICC.

Practical communication guidance to improve phase 1 informed consent conversations and decision-making in pediatric oncology.

BACKGROUND: It can be difficult to explain pediatric phase 1 oncology trials to families of children with refractory cancer. Parents may misunderstand the information presented to them, and physicians may assume that certain topics are covered in the informed consent document and need not be discussed. Communication models can help to ensure effective discussions. METHODS: Suggestions for improving the informed consent process were first solicited from phase 1 study clinicians via questionnaire. Eight parents who had enrolled their child on a phase 1 pediatric oncology trial were recruited for an advisory group designed to assess the clinicians' suggestions and make additional recommendations for improving informed consent for pediatric phase 1 trials. RESULTS: A phase 1 communication model was designed to incorporate the suggestions of clinicians and families. It focused on educating parents/families about phase 1 trials at specific time points during a child's illness, but specifically at the point of disease recurrence. An informative phase 1 fact sheet that can be distributed to families was also presented. CONCLUSIONS: Families who will be offered information regarding phase 1 clinical trials can first receive a standardized fact sheet explaining the general purpose of these early-phase clinical trials. Parental understanding may be enhanced further when oncologists address key themes, beginning at the time of diagnosis and continuing through important decision points during the child's illness. This model should be prospectively evaluated.

A first look at women's perspectives on noninvasive prenatal testing to detect sex chromosome aneuploidies and microdeletion syndromes.

OBJECTIVE: The aim of this study is to explore women's opinions about the use of noninvasive prenatal testing (NIPT) to assess the risk of sex chromosome aneuploidies and microdeletion syndromes. METHODS: Focus groups were conducted with women who were currently pregnant or had recently delivered. Qualitative analysis using interpretive description was used to generate study findings. RESULTS: Thirty-one women (mean age 32.4 years) participated in the focus groups. Participants were unfamiliar with sex chromosome aneuploidies but expressed support for the use of NIPT to detect these conditions. Participants were uncertain about the utility and actionability of receiving information about microdeletion syndromes with variable or unknown phenotypic expression. Participants voiced their desire to be informed of all conditions assessed by NIPT prior to testing. They considered clinicians to be the key provider of such information, although stated that patients have a responsibility to be knowledgeable prior to testing in order to support informed decision making. CONCLUSIONS: The use of NIPT to identify sex chromosome aneuploidies and microdeletion syndromes will introduce new challenges for clinicians to ensure pregnant women have the information and resources to make informed choices about NIPT when used for these conditions.

Hope and persuasion by physicians during informed consent.

PURPOSE: To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. PATIENTS AND METHODS: Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. RESULTS: The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. CONCLUSION: Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain.

Patient involvement in informed consent for pediatric phase I cancer research.

OBJECTIVE: To examine children's and adolescents' involvement in the informed consent conference for phase I cancer trials and test associations with patient age, ease of understanding, and pressure to participate. PROCEDURE: Participants included 61 patients aged 7 through 21 years who were offered participation in a phase I trial. Consent conferences were audiotaped, transcribed, and coded for communication between patients and physicians and between patients and parents. RESULTS: On the basis of word counts, the mean proportion of the consent conference in which the physician was talking to the patient was 36%; the vast majority (73%) of this communication consisted of giving information. Physician-patient communication increased with age, but overall levels of patient-to-physician communication were low (3%). After controlling for patient age, greater physician-to-patient communication was associated with greater ease of understanding. CONCLUSIONS: The focus on providing information in the context of informed consent may come at the expense of other communication exchanges that are important to patients, especially in the context of end-of-life decisions. Children and adolescents may benefit from the assent process when physicians direct more of their communication to them. Future research should identify the reasons for low patient communication during the consent conference and strategies to enhance their participation in decision making about phase I trial enrollment.

Suggestions from adolescents, young adults, and parents for improving informed consent in phase 1 pediatric oncology trials.

BACKGROUND: Informed consent for a pediatric oncology phase 1 trial is a delicate process, and is made more complex by the difficulty of the information and the requirement for parental consent, and patient assent when applicable. This analysis identifies suggestions for improving the informed consent process received from parents and adolescent and young adult patients (aged 14 years-21 years) who had the option of participating in a phase 1 pediatric oncology trial. METHODS: A total of 57 parents and 20 patients completed interviews as part of a multisite, prospective, descriptive study. These transcribed interviews were studied using established content analysis methods. RESULTS: Parent and patient responses contained 220 suggestions and 54 suggestions, respectively. A total of 21 unique suggestions for improvement emerged in 3 main themes: 1) provision of more information; 2) structure and presentation of the informed consent process, and 3) suggestions for physicians conducting the process. Common suggestions included providing more specific information about the trial, allowing more time for decision-making, and using different methods to deliver information. CONCLUSIONS: Participants involved in the informed consent process for a phase 1 trial provided specific recommendations to research teams to enhance the process. Physician/investigators should be informed of these recommendations and develop and test interventions incorporating them.

Adolescent perspectives on phase I cancer research.

BACKGROUND: The aim of this study was to examine adolescent patients' perspectives on their understanding and decision making about a pediatric phase I cancer study. PROCEDURE: Participants included adolescents ages 14-21 years with cancer (N = 20), all of whom attended a phase I study consent conference. Participants responded to closed- and open-ended questions on a verbally administered structured interview, which assessed aspects of understanding and decision making about the phase I study. RESULTS: All participants decided to enroll in the phase I study. The majority of participants understood that participation was voluntary, entailed risks, and that they could withdraw. Most also believed that participation in the phase I study would increase the length of their lives. The most frequent reasons for enrolling were positive clinical benefit, needing an option, impact on quality of life, and few side effects or fewer than those of current or past treatments. Eighty-five percent of participants reported that they themselves made the final decision about enrollment in the phase I study. CONCLUSIONS: Most participants hoped or expected that the phase I study would provide a direct benefit (increased survival time or cure) and reported that they themselves were the final decision-maker about enrollment. Clinicians may underestimate the role of adolescents, especially if they believe that parents typically make such decisions. Future research should assess the actual participation of children and adolescents during the informed consent process and explore the role of hope in their decision making about phase I studies.

Negotiating decisions during informed consent for pediatric Phase I oncology trials.

During informed consent conferences (ICCs) for Phase I trials, oncologists must present complex information while addressing concerns. Research on communication that evolves during ICCs remains largely unexplored. We examined communication during ICCs for pediatric Phase I cancer trials using a stratified random sample from six pediatric cancer centers. A grounded theory approach identified key communication steps and factors influencing the negotiation of decisions for trial participation. Analysis suggests that during ICCs, families, patients, and clinicians exercise choice and control by negotiating micro-decisions in two broad domains: drug logic and logistics, and administration/scheduling. Micro-decisions unfold in a four-step communication process: (1) introduction of an issue; (2) response; (3) negotiation of the issue; and (4) resolution and decision. Negotiation over smaller micro-decisions is prominent in ICCs and merits further study.