Engineering topics
Walton, Marlei
Publications and source records attributed to Walton, Marlei.
A Quantitative Risk-Benefit Analysis of Prophylactic Surgery Prior to Extended-Duration Spaceflight
INTRODUCTION: Among otherwise healthy astronauts undertaking deep space missions, the risks for acute appendicitis (AA) and cholecystitis (AC) are not zero. If these conditions were to occur during spaceflight they may require surgery for definitive care. The proposed study quantifies and compares the risks of developing de novo AA and AC in-flight to the surgical risks of prophylactic laparoscopic appendectomy (LA) and cholecystectomy (LC) using NASA's Integrated Medical Model (IMM). METHODS: The IMM is a Monte Carlo simulation that forecasts medical events during spaceflight missions and estimates the impact of these medical events on crew health. In this study, four Design Reference Missions (DRMs) were created to assess the probability of an astronaut developing in-flight small-bowel obstruction (SBO) following prophylactic 1) LA, 2) LC, 3) LA and LC, or 4) neither surgery (SR# S-20160407-351). Model inputs were drawn from a large, population-based 2011 Swedish study that examined the incidence and risks of post-operative SBO over a 5-year follow-up period. The study group included 1,152 patients who underwent LA, and 16,371 who underwent LC. RESULTS: Preliminary results indicate that prophylactic LA may yield higher mission risks than the control DRM. Complete analyses are pending and will be subsequently available. DISCUSSION: The risk versus benefits of prophylactic surgery in astronauts to decrease the probability of acute surgical events during spaceflight has only been qualitatively examined in prior studies. Within the assumptions and limitations of the IMM, this work provides the first quantitative guidance that has previously been lacking to this important question for future deep space exploration missions.
A Risk-Benefit Analysis of Prophylactic Surgery Before Extended-Duration Spaceflight
No abstract available
The Integrated Medical Model: A Probabilistic Simulation Model Predicting In-Flight Medical Risks
The Integrated Medical Model (IMM) is a probabilistic model that uses simulation to predict mission medical risk. Given a specific mission and crew scenario, medical events are simulated using Monte Carlo methodology to provide estimates of resource utilization, probability of evacuation, probability of loss of crew, and the amount of mission time lost due to illness. Mission and crew scenarios are defined by mission length, extravehicular activity (EVA) schedule, and crew characteristics including: sex, coronary artery calcium score, contacts, dental crowns, history of abdominal surgery, and EVA eligibility. The Integrated Medical Evidence Database (iMED) houses the model inputs for one hundred medical conditions using in-flight, analog, and terrestrial medical data. Inputs include incidence, event durations, resource utilization, and crew functional impairment. Severity of conditions is addressed by defining statistical distributions on the dichotomized best and worst-case scenarios for each condition. The outcome distributions for conditions are bounded by the treatment extremes of the fully treated scenario in which all required resources are available and the untreated scenario in which no required resources are available. Upon occurrence of a simulated medical event, treatment availability is assessed, and outcomes are generated depending on the status of the affected crewmember at the time of onset, including any pre-existing functional impairments or ongoing treatment of concurrent conditions. The main IMM outcomes, including probability of evacuation and loss of crew life, time lost due to medical events, and resource utilization, are useful in informing mission planning decisions. To date, the IMM has been used to assess mission-specific risks with and without certain crewmember characteristics, to determine the impact of eliminating certain resources from the mission medical kit, and to design medical kits that maximally benefit crew health while meeting mass and volume constraints.
The Integrated Medical Model: A Probabilistic Simulation Model for Predicting In-Flight Medical Risks
The Integrated Medical Model (IMM) is a probabilistic model that uses simulation to predict mission medical risk. Given a specific mission and crew scenario, medical events are simulated using Monte Carlo methodology to provide estimates of resource utilization, probability of evacuation, probability of loss of crew, and the amount of mission time lost due to illness. Mission and crew scenarios are defined by mission length, extravehicular activity (EVA) schedule, and crew characteristics including: sex, coronary artery calcium score, contacts, dental crowns, history of abdominal surgery, and EVA eligibility. The Integrated Medical Evidence Database (iMED) houses the model inputs for one hundred medical conditions using in-flight, analog, and terrestrial medical data. Inputs include incidence, event durations, resource utilization, and crew functional impairment. Severity of conditions is addressed by defining statistical distributions on the dichotomized best and worst-case scenarios for each condition. The outcome distributions for conditions are bounded by the treatment extremes of the fully treated scenario in which all required resources are available and the untreated scenario in which no required resources are available. Upon occurrence of a simulated medical event, treatment availability is assessed, and outcomes are generated depending on the status of the affected crewmember at the time of onset, including any pre-existing functional impairments or ongoing treatment of concurrent conditions. The main IMM outcomes, including probability of evacuation and loss of crew life, time lost due to medical events, and resource utilization, are useful in informing mission planning decisions. To date, the IMM has been used to assess mission-specific risks with and without certain crewmember characteristics, to determine the impact of eliminating certain resources from the mission medical kit, and to design medical kits that maximally benefit crew health while meeting mass and volume constraints.
Can We Trust Computational Modeling for Medical Applications?
Operations in extreme environments such as spaceflight pose human health risks that are currently not well understood and potentially unanticipated. In addition, there are limited clinical and research data to inform development and implementation of therapeutics for these unique health risks. In this light, NASA's Human Research Program (HRP) is leveraging biomedical computational models and simulations (M&S) to help inform, predict, assess and mitigate spaceflight health and performance risks, and enhance countermeasure development. To ensure that these M&S can be applied with confidence to the space environment, it is imperative to incorporate a rigorous verification, validation and credibility assessment (VV&C) processes to ensure that the computational tools are sufficiently reliable to answer questions within their intended use domain. In this presentation, we will discuss how NASA's Integrated Medical Model (IMM) and Digital Astronaut Project (DAP) have successfully adapted NASA's Standard for Models and Simulations, NASA-STD-7009 (7009) to achieve this goal. These VV&C methods are also being leveraged by organization such as the Food and Drug Administration (FDA), National Institute of Health (NIH) and the American Society of Mechanical Engineers (ASME) to establish new M&S VV&C standards and guidelines for healthcare applications. Similarly, we hope to provide some insight to the greater aerospace medicine community on how to develop and implement M&S with sufficient confidence to augment medical research and operations.
Credibility Assessment of Deterministic Computational Models and Simulations for Space Biomedical Research and Operations
Human missions beyond low earth orbit to destinations, such as to Mars and asteroids will expose astronauts to novel operational conditions that may pose health risks that are currently not well understood and perhaps unanticipated. In addition, there are limited clinical and research data to inform development and implementation of health risk countermeasures for these missions. Consequently, NASA's Digital Astronaut Project (DAP) is working to develop and implement computational models and simulations (M&S) to help predict and assess spaceflight health and performance risks, and enhance countermeasure development. In order to effectively accomplish these goals, the DAP evaluates its models and simulations via a rigorous verification, validation and credibility assessment process to ensure that the computational tools are sufficiently reliable to both inform research intended to mitigate potential risk as well as guide countermeasure development. In doing so, DAP works closely with end-users, such as space life science researchers, to establish appropriate M&S credibility thresholds. We will present and demonstrate the process the DAP uses to vet computational M&S for space biomedical analysis using real M&S examples. We will also provide recommendations on how the larger space biomedical community can employ these concepts to enhance the credibility of their M&S codes.
Integrated Medical Model Verification, Validation, and Credibility
The Integrated Medical Model (IMM) was designed to forecast relative changes for a specified set of crew health and mission success risk metrics by using a probabilistic (stochastic process) model based on historical data, cohort data, and subject matter expert opinion. A probabilistic approach is taken since exact (deterministic) results would not appropriately reflect the uncertainty in the IMM inputs. Once the IMM was conceptualized, a plan was needed to rigorously assess input information, framework and code, and output results of the IMM, and ensure that end user requests and requirements were considered during all stages of model development and implementation. METHODS: In 2008, the IMM team developed a comprehensive verification and validation (VV) plan, which specified internal and external review criteria encompassing 1) verification of data and IMM structure to ensure proper implementation of the IMM, 2) several validation techniques to confirm that the simulation capability of the IMM appropriately represents occurrences and consequences of medical conditions during space missions, and 3) credibility processes to develop user confidence in the information derived from the IMM. When the NASA-STD-7009 (7009) was published, the IMM team updated their verification, validation, and credibility (VVC) project plan to meet 7009 requirements and include 7009 tools in reporting VVC status of the IMM. RESULTS: IMM VVC updates are compiled recurrently and include 7009 Compliance and Credibility matrices, IMM VV Plan status, and a synopsis of any changes or updates to the IMM during the reporting period. Reporting tools have evolved over the lifetime of the IMM project to better communicate VVC status. This has included refining original 7009 methodology with augmentation from the NASA-STD-7009 Guidance Document. End user requests and requirements are being satisfied as evidenced by ISS Program acceptance of IMM risk forecasts, transition to an operational model and simulation tool, and completion of service requests from a broad end user consortium including Operations, Science and Technology Planning, and Exploration Planning. CONCLUSIONS: The VVC approach established by the IMM project of combining the IMM VV Plan with 7009 requirements is comprehensive and includes the involvement of end users at every stage in IMM evolution. Methods and techniques used to quantify the VVC status of the IMM have not only received approval from the local NASA community but have also garnered recognition by other federal agencies seeking to develop similar guidelines in the medical modeling community.
NASA-STD-7009 Guidance Document for Human Health and Performance Models and Simulations
Rigorous verification, validation, and credibility (VVC) processes are imperative to ensure that models and simulations (MS) are sufficiently reliable to address issues within their intended scope. The NASA standard for MS, NASA-STD-7009 (7009) [1] was a resultant outcome of the Columbia Accident Investigation Board (CAIB) to ensure MS are developed, applied, and interpreted appropriately for making decisions that may impact crew or mission safety. Because the 7009 focus is engineering systems, a NASA-STD-7009 Guidance Document is being developed to augment the 7009 and provide information, tools, and techniques applicable to the probabilistic and deterministic biological MS more prevalent in human health and performance (HHP) and space biomedical research and operations.
How to Develop and Interpret a Credibility Assessment of Numerical Models for Human Research: NASA-STD-7009 Demystified
In the wake of the Columbia accident, the NASA-STD-7009 [1] credibility assessment was developed as a unifying platform to describe model credibility and the uncertainties in its modeling predictions. This standard is now being adapted by NASAs Human Research Program to cover a wide range of numerical models for human research. When used properly, the standard can improve the process of code development by encouraging the use of best practices. It can also give management more insight in making informed decisions through a better understanding of the models capabilities and limitations.To a newcomer, the abstractions presented in NASA-STD-7009 and the sheer volume of information that must be absorbed can be overwhelming. This talk is aimed at describing the credibility assessment, which is the heart of the standard, in plain terms. It will outline how to develop a credibility assessment under the standard. It will also show how to quickly interpret the graphs and tables that result from the assessment and how to drill down from the top-level view to the foundation of the assessment. Finally, it will highlight some of the resources that are available for further study.
HRP's Healthcare Spin-Offs Through Computational Modeling and Simulation Practice Methodologies
Spaceflight missions expose astronauts to novel operational and environmental conditions that pose health risks that are currently not well understood, and perhaps unanticipated. Furthermore, given the limited number of humans that have flown in long duration missions and beyond low Earth-orbit, the amount of research and clinical data necessary to predict and mitigate these health and performance risks are limited. Consequently, NASA's Human Research Program (HRP) conducts research and develops advanced methods and tools to predict, assess, and mitigate potential hazards to the health of astronauts. In this light, NASA has explored the possibility of leveraging computational modeling since the 1970s as a means to elucidate the physiologic risks of spaceflight and develop countermeasures. Since that time, substantial progress has been realized in this arena through a number of HRP funded activates such as the Digital Astronaut Project (DAP) and the Integrated Medical Model (IMM). Much of this success can be attributed to HRP's endeavor to establish rigorous verification, validation, and credibility (VV&C) processes that ensure computational models and simulations (M&S) are sufficiently credible to address issues within their intended scope. This presentation summarizes HRP's activities in credibility of modeling and simulation, in particular through its outreach to the community of modeling and simulation practitioners. METHODS: The HRP requires all M&S that can have moderate to high impact on crew health or mission success must be vetted in accordance to NASA Standard for Models and Simulations, NASA-STD-7009 (7009) [5]. As this standard mostly focuses on engineering systems, the IMM and DAP have invested substantial efforts to adapt the processes established in this standard for their application to biological M&S, which is more prevalent in human health and performance (HHP) and space biomedical research and operations [6,7]. These methods have also generated substantial interest by the broader medical community though institutions like the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to develop similar standards and guidelines applicable to the larger medical operations and research community. DISCUSSION: Similar to NASA, many leading government agencies, health institutions and medical product developers around the world are recognizing the potential of computational M&S to support clinical research and decision making. In this light, substantial investments are being made in computational medicine and notable discoveries are being realized [8]. However, there is a lack of broadly applicable practice guidance for the development and implementation of M&S in clinical care and research in a manner that instills confidence among medical practitioners and biological researchers [9,10]. In this presentation, we will give an overview on how HRP is working with the NIH's Interagency Modeling and Analysis Group (IMAG), the FDA and the American Society of Mechanical Engineers (ASME) to leverage NASA's biomedical VV&C processes to establish a new regulatory standard for Verification and Validation in Computational Modeling of Medical Devices, and Guidelines for Credible Practice of Computational Modeling and Simulation in Healthcare.
Integration of an Evidence Base into a Probabilistic Risk Assessment Model. The Integrated Medical Model Database: An Organized Evidence Base for Assessing In-Flight Crew Health Risk and System Design
This slide presentation reviews the Integrated Medical Model (IMM) database, which is an organized evidence base for assessing in-flight crew health risk. The database is a relational database accessible to many people. The database quantifies the model inputs by a ranking based on the highest value of the data as Level of Evidence (LOE) and the quality of evidence (QOE) score that provides an assessment of the evidence base for each medical condition. The IMM evidence base has already been able to provide invaluable information for designers, and for other uses.
Integration of Evidence Base into a Probabilistic Risk Assessment
INTRODUCTION: A probabilistic decision support model such as the Integrated Medical Model (IMM) utilizes an immense amount of input data that necessitates a systematic, integrated approach for data collection, and management. As a result of this approach, IMM is able to forecasts medical events, resource utilization and crew health during space flight. METHODS: Inflight data is the most desirable input for the Integrated Medical Model. Non-attributable inflight data is collected from the Lifetime Surveillance for Astronaut Health study as well as the engineers, flight surgeons, and astronauts themselves. When inflight data is unavailable cohort studies, other models and Bayesian analyses are used, in addition to subject matters experts input on occasion. To determine the quality of evidence of a medical condition, the data source is categorized and assigned a level of evidence from 1-5; the highest level is one. The collected data reside and are managed in a relational SQL database with a web-based interface for data entry and review. The database is also capable of interfacing with outside applications which expands capabilities within the database itself. Via the public interface, customers can access a formatted Clinical Findings Form (CLiFF) that outlines the model input and evidence base for each medical condition. Changes to the database are tracked using a documented Configuration Management process. DISSCUSSION: This strategic approach provides a comprehensive data management plan for IMM. The IMM Database s structure and architecture has proven to support additional usages. As seen by the resources utilization across medical conditions analysis. In addition, the IMM Database s web-based interface provides a user-friendly format for customers to browse and download the clinical information for medical conditions. It is this type of functionality that will provide Exploratory Medicine Capabilities the evidence base for their medical condition list. CONCLUSION: The IMM Database in junction with the IMM is helping NASA aerospace program improve the health care and reduce risk for the astronauts crew. Both the database and model will continue to expand to meet customer needs through its multi-disciplinary evidence based approach to managing data. Future expansion could serve as a platform for a Space Medicine Wiki of medical conditions.
The Use of the Integrated Medical Model for Forecasting and Mitigating Medical Risks for a Near-Earth Asteroid Mission
Introduction The Integrated Medical Model (IMM) is a decision support tool that is useful to space flight mission managers and medical system designers in assessing risks and optimizing medical systems. The IMM employs an evidence-based, probabilistic risk assessment (PRA) approach within the operational constraints of space flight. Methods Stochastic computational methods are used to forecast probability distributions of medical events, crew health metrics, medical resource utilization, and probability estimates of medical evacuation and loss of crew life. The IMM can also optimize medical kits within the constraints of mass and volume for specified missions. The IMM was used to forecast medical evacuation and loss of crew life probabilities, as well as crew health metrics for a near-earth asteroid (NEA) mission. An optimized medical kit for this mission was proposed based on the IMM simulation. Discussion The IMM can provide information to the space program regarding medical risks, including crew medical impairment, medical evacuation and loss of crew life. This information is valuable to mission managers and the space medicine community in assessing risk and developing mitigation strategies. Exploration missions such as NEA missions will have significant mass and volume constraints applied to the medical system. Appropriate allocation of medical resources will be critical to mission success. The IMM capability of optimizing medical systems based on specific crew and mission profiles will be advantageous to medical system designers. Conclusion The IMM is a decision support tool that can provide estimates of the impact of medical events on human space flight missions, such as crew impairment, evacuation, and loss of crew life. It can be used to support the development of mitigation strategies and to propose optimized medical systems for specified space flight missions. Learning Objectives The audience will learn how an evidence-based decision support tool can be used to help assess risk, develop mitigation strategies, and optimize medical systems for exploration space flight missions.
The Integrated Medical Model
The goals of the Integrated Medical Model (IMM) are to develop an integrated, quantified, evidence-based decision support tool useful to crew health and mission planners and to help align science, technology, and operational activities intended to optimize crew health, safety, and mission success. Presentation slides address scope and approach, beneficiaries of IMM capabilities, history, risk components, conceptual models, development steps, and the evidence base. Space adaptation syndrome is used to demonstrate the model's capabilities.
The Integrated Medical Model - A Risk Assessment and Decision Support Tool for Human Space Flight Missions
The Integrated Medical Model (IMM) is a decision support tool that is useful to space flight mission planners and medical system designers in assessing risks and optimizing medical systems. The IMM employs an evidence-based, probabilistic risk assessment (PRA) approach within the operational constraints of space flight.
The Integrated Medical Model - Optimizing In-flight Space Medical Systems to Reduce Crew Health Risk and Mission Impacts
The Integrated Medical Model (IMM) is a decision support tool used by medical system planners and designers as they prepare for exploration planning activities of the Constellation program (CxP). IMM provides an evidence-based approach to help optimize the allocation of in-flight medical resources for a specified level of risk within spacecraft operational constraints. Eighty medical conditions and associated resources are represented in IMM. Nine conditions are due to Space Adaptation Syndrome. The IMM helps answer fundamental medical mission planning questions such as What medical conditions can be expected? What type and quantity of medical resources are most likely to be used?", and "What is the probability of crew death or evacuation due to medical events?" For a specified mission and crew profile, the IMM effectively characterizes the sequence of events that could potentially occur should a medical condition happen. The mathematical relationships among mission and crew attributes, medical conditions and incidence data, in-flight medical resources, potential clinical and crew health end states are established to generate end state probabilities. A Monte Carlo computational method is used to determine the probable outcomes and requires up to 25,000 mission trials to reach convergence. For each mission trial, the pharmaceuticals and supplies required to diagnose and treat prevalent medical conditions are tracked and decremented. The uncertainty of patient response to treatment is bounded via a best-case, worst-case, untreated case algorithm. A Crew Health Index (CHI) metric, developed to account for functional impairment due to a medical condition, provides a quantified measure of risk and enables risk comparisons across mission scenarios. The use of historical in-flight medical data, terrestrial surrogate data as appropriate, and space medicine subject matter expertise has enabled the development of a probabilistic, stochastic decision support tool capable of optimizing in-flight medical systems based on crew and mission parameters. This presentation will illustrate how to apply quantitative risk assessment methods to optimize the mass and volume of space-based medical systems for a space flight mission given the level of crew health and mission risk.