ALBERT

Description: 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.

Description: 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.

Description: 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.

Description: This slide presentation reviews the Integrated Medical Model (IMM) and its use as a risk assessment and decision support tool for human space flight missions. The IMM is an integrated, quantified, evidence-based decision support tool useful to NASA crew health and mission planners. It is intended to assist in optimizing crew health, safety and mission success within the constraints of the space flight environment for in-flight operations. It uses ISS data to assist in planning for the Exploration Program and it is not intended to assist in post flight research. The IMM was used to update Probability Risk Assessment (PRA) for the purpose of updating forecasts for the conditions requiring evacuation (EVAC) or Loss of Crew Life (LOC) for the ISS. The IMM validation approach includes comparison with actual events and involves both qualitative and quantitaive approaches. The results of these comparisons are reviewed. Another use of the IMM is to optimize the medical kits taking into consideration the specific mission and the crew profile. An example of the use of the IMM to optimize the medical kits is reviewed.

Description: 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.

Description: 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.

Description: 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.

Description: 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.

Description: 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.

Description: The Integrated Medical Model (IMM) utilizes Monte Carlo methodologies to predict the occurrence of medical events, utilization of resources, and clinical outcomes during space flight. Real-world data may be used to demonstrate the accuracy of the model. For this analysis, IMM predictions were compared to data from historical shuttle missions, not yet included as model source input. Initial goodness of fit test-ing on International Space Station data suggests that the IMM may overestimate the number of occurrences for three of the 83 medical conditions in the model. The IMM did not underestimate the occurrence of any medical condition. Initial comparisons with shuttle data demonstrate the importance of understanding crew preference (i.e., preferred analgesic) for accurately predicting the utilization of re-sources. The initial analysis demonstrates the validity of the IMM for its intended use and highlights areas for improvement.