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A Comparison of Expedition Medical Condition List Treatment Directives with Integrated Medical Model Simulation Data Presentation and Briefing Report

This aerospace medicine clerkship project is under the direction of Dr. Sharmila Watkins and is in cooperation with Dr. Eric Kerstman and Dr. Ronak Shah. The questions of the research project are: 1. What are the main drivers of evacuation and loss of crew life (LOCL) on three Design Reference Missions (DRMs): Near Earth Asteroid (NEA), Lunar Sortie and Lunar Outpost using an inexhaustible International Space Station medical kit 2. What are the treatment designations for these driving medical conditions as listed in Expedition Medical Condition List (EMCL) 3. Do the drivers make sense in the context of the given Design Reference Mission (DRM) 4. Do any EMCL treatment designations need re-assessing.

Lewis, Robert↗

Integrated Medical Model (IMM) Optimization Version 4.0 Functional Improvements

The IMMs ability to assess mission outcome risk levels relative to available resources provides a unique capability to provide guidance on optimal operational medical kit and vehicle resources. Post-processing optimization allows IMM to optimize essential resources to improve a specific model outcome such as maximization of the Crew Health Index (CHI), or minimization of the probability of evacuation (EVAC) or the loss of crew life (LOCL). Mass and or volume constrain the optimized resource set. The IMMs probabilistic simulation uses input data on one hundred medical conditions to simulate medical events that may occur in spaceflight, the resources required to treat those events, and the resulting impact to the mission based on specific crew and mission characteristics. Because IMM version 4.0 provides for partial treatment for medical events, IMM Optimization 4.0 scores resources at the individual resource unit increment level as opposed to the full condition-specific treatment set level, as done in version 3.0. This allows the inclusion of as many resources as possible in the event that an entire set of resources called out for treatment cannot satisfy the constraints. IMM Optimization version 4.0 adds capabilities that increase efficiency by creating multiple resource sets based on differing constraints and priorities, CHI, EVAC, or LOCL. It also provides sets of resources that improve mission-related IMM v4.0 outputs with improved performance compared to the prior optimization. The new optimization represents much improved fidelity that will improve the utility of the IMM 4.0 for decision support.

risk assessment↗

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.

Saile, Lyn↗

Analysis of Advanced Respiratory Support Onboard ISS and CCV

NASA is collaborating with private entities for the development of commercial space vehicles. The Space and Clinical Operations Division was tasked to review the oxygen and respiratory support system and recommend what capabilities, if any, the vehicle should have to support the return of an ill or injured crewmember. The Integrated Medical Model (IMM) was utilized as a data source for the development of these recommendations. The Integrated Medical Model (IMM) was used to simulate a six month, six crew, International Space Station (ISS) mission. Three medical system scenarios were considered based on the availability of (1) oxygen only, (2) oxygen and a ventilator, or (3) neither oxygen nor ventilator. The IMM analysis provided probability estimates of medical events that would require either oxygen or ventilator support. It also provided estimates of crew health, the probability of evacuation, and the probability of loss of crew life secondary to medical events for each of the three medical system scenarios. These IMM outputs were used as objective data to enable evidence‐based decisions regarding oxygen and respiratory support system requirements for commercial crew vehicles. The IMM provides data that may be utilized to support informed decisions regarding the development of medical systems for commercial crew vehicles.

Shah, Ronak V.↗

Risks from Solar Particle Events for Long Duration Space Missions Outside Low Earth Orbit

The Integrated Medical Model (IMM) simulates the medical occurrences and mission outcomes for various mission profiles using probabilistic risk assessment techniques. As part of the work with the Integrated Medical Model (IMM), this project focuses on radiation risks from acute events during extended human missions outside low Earth orbit (LEO). Of primary importance in acute risk assessment are solar particle events (SPEs), which are low probability, high consequence events that could adversely affect mission outcomes through acute radiation damage to astronauts. SPEs can be further classified into coronal mass ejections (CMEs) and solar flares/impulsive events (Fig. 1). CMEs are an eruption of solar material and have shock enhancements that contribute to make these types of events higher in total fluence than impulsive events.

health↗

Optimizing Medical Kits for Spaceflight

The Integrated Medical Model (IMM) is a probabilistic model that estimates medical event occurrences and mission outcomes for different mission profiles. IMM simulation outcomes describing the impact of medical events on the mission may be used to optimize the allocation of resources in medical kits. Efficient allocation of medical resources, subject to certain mass and volume constraints, is crucial to ensuring the best outcomes of in-flight medical events. We implement a new approach to this medical kit optimization problem. METHODS We frame medical kit optimization as a modified knapsack problem and implement an algorithm utilizing a dynamic programming technique. Using this algorithm, optimized medical kits were generated for 3 different mission scenarios with the goal of minimizing the probability of evacuation and maximizing the Crew Health Index (CHI) for each mission subject to mass and volume constraints. Simulation outcomes using these kits were also compared to outcomes using kits optimized..RESULTS The optimized medical kits generated by the algorithm described here resulted in predicted mission outcomes more closely approached the unlimited-resource scenario for Crew Health Index (CHI) than the implementation in under all optimization priorities. Furthermore, the approach described here improves upon in reducing evacuation when the optimization priority is minimizing the probability of evacuation. CONCLUSIONS This algorithm provides an efficient, effective means to objectively allocate medical resources for spaceflight missions using the Integrated Medical Model.

Optimization↗

IMPACT 1.0—Task Impairment: A Novel Approach for Assessing Impairment during Exploration-Class Missions

Exploration-class and International Space Station (ISS) missions have significantly different levels of associated medical risk for crewmembers. The Integrated Medical Model (IMM), the probabilistic risk assessment tool used for ISS medical trade-space analyses, uses a Functional Impairment (FI) metric to determine quality time lost should a crewmember be afflicted with a medical condition. While IMM-based FI has been successful for ISS operations, it has limitations when applied to exploration-class missions. As the National Aeronautics and Space Administration (NASA) looks ahead to Gateway, Artemis, and Martian missions, a novel, dynamic, and mission-appropriate impairment paradigm is necessary for accurate contingency planning. This paradigm, Task Impairment (TI), fulfills that need by utilizing mission-specific tasks. TI will allow future capability for a loss of mission metric, previously not available with IMM. TI serves as a replacement metric for FI within IMPACT, the next-generation trade-space analysis tool suite created to replace the IMM. IMPACT significantly increases the fidelity of probabilistic risk assessment for exploration-class missions. The Human Exploration of Mars Preliminary List of Crew Tasks (MTL, a source of 1100+ exploration-class mission-specific tasks for crewmembers) was used to calculate TI. Using the Task List, 18 individual Human System Categories were identified as being required to perform each task (e.g., Cardiopulmonary, Cognitive, etc.). Each of the 1200+ tasks were mapped to the Human System categories listed in the Task List. The total number of tasks in each category were tallied to determine how many tasks required each Human System. Lastly, each of the 120 medical conditions from the IMPACT condition list were mapped to the Human System categories to complete the TI calculation. NASA subject matter experts across five medical specialties established consensus for the mapping of each condition. The resulting total tasks impaired by each condition were used to calculate discrete TI values. This process was repeated for each of the four severity/resource utilization variants of each condition, and for each of the three phases of clinical care. Through this process, discrete TI values were calculated for each of the 120 IMPACT medical conditions and their variants. The Task Impairment metric provides higher fidelity, dynamic utility, and quicker analysis of medical impairment compared to the previous Functional Impairment metric used for the Integrated Medical Model. TI will be used for higher fidelity medical impairment analysis and contingency planning during Lunar, Martian, and other long-term exploration-class missions.

William L Fernandez↗

Crowd Sourcing Medical Data Collection Using Medical Students

OBJECTIVE We undertook an upgrade of the Evidence Library database of NASA HRP’s Integrated Medical Model, assessing 120 medical conditions which integrate with a novel probabilistic risk assessment (IMPACT) tool of medical risk and resource utilization for long duration exploration human spaceflight. This data collection process included a selection of these conditions crowd sourced over one year via three 4-week medical student electives at the University of Colorado School of Medicine (IDPT 8059 Space Medicine: Human Spaceflight Factors & Medical Risk Assessment). Students undertook a rapid systematic review of each medical condition, under close preceptors with backgrounds in clinical medicine, library science, epidemiology, biostatistics, and evidence-based medicine. As part of the elective, students also received instruction in core space medicine concepts, evidence based medicine and problem based learning sessions as a flight surgeon supporting a simulated Mars mission. METHODS The list of 120 medical conditions includes both common, terrestrial illness/injury (epistaxis, diverticulitis) as well as spaceflight-specific ones (space adaptation conditions, EVA-related injuries). A rapid systematic review process was developed that would allow students to find the data for determining disease incidence/prevalence, return to definitive care (often a surrogate such as hospitalization rates), loss of crew life, and treatment duration. Each data point required a tailored, specialized search process using different databases and corresponding specialized search filters. Databases were selected on their ability to provide high quality literature in an efficient manner and prioritized by their ability to provide graded evidence via a set rubrics specific to human spaceflight. Students were responsible for performing all literature searches and identifying the highest quality available evidence for each data point. Completed student data sheets underwent initial review by faculty preceptors followed by a secondary editing review by the ExMC Clinical Science Team. RESULTS Over the course of three electives, approximately 105 medical conditions were researched by students using spreadsheets with pre-crafted search strategies. Overall, this process was successful in allowing students to perform the preponderance of work to update incidence, treatment duration, return to definitive care, and loss of crew life data points. Students were successful in running searches, identifying the necessary data points within the literature, and determining the types of terrestrial data that most aligns with the astronaut population for successful completion of their tasks. Limitations included variable student experience with search methodologies [PubMed], differing values of evidence grading [best practice evidence based medicine vs. relevant to spaceflight], and students’ unfamiliarity with spaceflight specific conditions. CONCLUSION Finding the relevant literature for medical conditions in spaceflight within terrestrial databases in a systematic method is time consuming and not intuitive. However, the stepwise process that balanced sensitivity with specificity allowed for students to be highly successful in a short amount of time. Additionally, as the process was refined over the course of three electives, preceptors were better able to anticipate where students were likely to encounter barriers, which allowed the course to be adjusted to account for certain data points needing more time for completion. This replicable process may be an efficient way to accomplish rapid systematic reviews for a large volume of data in a short amount of time.

J Lemery↗

Probabilistic Modeling of the Renal Stone Formation Module

The Integrated Medical Model (IMM) is a probabilistic tool, used in mission planning decision making and medical systems risk assessments. The IMM project maintains a database of over 80 medical conditions that could occur during a spaceflight, documenting an incidence rate and end case scenarios for each. In some cases, where observational data are insufficient to adequately define the inflight medical risk, the IMM utilizes external probabilistic modules to model and estimate the event likelihoods. One such medical event of interest is an unpassed renal stone. Due to a high salt diet and high concentrations of calcium in the blood (due to bone depletion caused by unloading in the microgravity environment) astronauts are at a considerable elevated risk for developing renal calculi (nephrolithiasis) while in space. Lack of observed incidences of nephrolithiasis has led HRP to initiate the development of the Renal Stone Formation Module (RSFM) to create a probabilistic simulator capable of estimating the likelihood of symptomatic renal stone presentation in astronauts on exploration missions. The model consists of two major parts. The first is the probabilistic component, which utilizes probability distributions to assess the range of urine electrolyte parameters and a multivariate regression to transform estimated crystal density and size distributions to the likelihood of the presentation of nephrolithiasis symptoms. The second is a deterministic physical and chemical model of renal stone growth in the kidney developed by Kassemi et al. The probabilistic component of the renal stone model couples the input probability distributions describing the urine chemistry, astronaut physiology, and system parameters with the physical and chemical outputs and inputs to the deterministic stone growth model. These two parts of the model are necessary to capture the uncertainty in the likelihood estimate. The model will be driven by Monte Carlo simulations, continuously randomly sampling the probability distributions of the electrolyte concentrations and system parameters that are inputs into the deterministic model. The total urine chemistry concentrations are used to determine the urine chemistry activity using the Joint Expert Speciation System (JESS), a biochemistry model. Information used from JESS is then fed into the deterministic growth model. Outputs from JESS and the deterministic model are passed back to the probabilistic model where a multivariate regression is used to assess the likelihood of a stone forming and the likelihood of a stone requiring clinical intervention. The parameters used to determine to quantify these risks include: relative supersaturation (RS) of calcium oxalate, citrate/calcium ratio, crystal number density, total urine volume, pH, magnesium excretion, maximum stone width, and ureteral location. Methods and Validation: The RSFM is designed to perform a Monte Carlo simulation to generate probability distributions of clinically significant renal stones, as well as provide an associated uncertainty in the estimate. Initially, early versions will be used to test integration of the components and assess component validation and verification (V&V), with later versions used to address questions regarding design reference mission scenarios. Once integrated with the deterministic component, the credibility assessment of the integrated model will follow NASA STD 7009 requirements.

kidney stones↗

Assessment of Model Outcomes between MEDPRAT and the IMM

- The Integrated Medical Model (IMM) is the accepted standard for quantifying spaceflight mission medical risk in NASA operations. - While MEDPRAT implemented a new, efficient architecture and new capability, it's basic functionality mimics that of the IMM. - How does the outcome for the same reference missions and input data compare between IMM and MEDPRAT V1 and MEDPRAT V2?

Clara Gasiewski↗

Qualitative Validation of the IMM Model for ISS and STS Programs

To validate and further improve the Integrated Medical Model (IMM), medical event data were obtained from 32 ISS and 122 STS person-missions. Using the crew characteristics from these observed missions, IMM v4.0 was used to forecast medical events and medical resource utilization. The IMM medical condition incidence values were compared to the actual observed medical event incidence values, and the IMM forecasted medical resource utilization was compared to actual observed medical resource utilization. Qualitative comparisons of these parameters were conducted for both the ISS and STS programs. The results of these analyses will provide validation of IMM v4.0 and reveal areas of the model requiring adjustments to improve the overall accuracy of IMM outputs. This validation effort should result in enhanced credibility of the IMM and improved confidence in the use of IMM as a decision support tool for human space flight.

risk assessment↗

Bridging the Engineering and Medicine Gap

A primary challenge NASA faces is communication between the disparate entities of engineers and human system experts in life sciences. Clear communication is critical for exploration mission success from the perspective of both risk analysis and data handling. The engineering community uses probabilistic risk assessment (PRA) models to inform their own risk analysis and has extensive experience managing mission data, but does not always fully consider human systems integration (HSI). The medical community, as a part of HSI, has been working 1) to develop a suite of tools to express medical risk in quantitative terms that are relatable to the engineering approaches commonly in use, and 2) to manage and integrate HSI data with engineering data. This talk will review the development of the Integrated Medical Model as an early attempt to bridge the communication gap between the medical and engineering communities in the language of PRA. This will also address data communication between the two entities in the context of data management considerations of the Medical Data Architecture. Lessons learned from these processes will help identify important elements to consider in future communication and integration of these two groups.

Walton, M.↗

Baseline Medical System Translation for the Impact Medical Database

NASA has developed a new evidence-based data-driven probabilistic risk assessment and tradespace analysis tool as a successor to the Integrated Medical Model (IMM). This updated decision support tool is known as IMPACT (Informing Mission Planning via Analysis of Complex Tradespaces). Whereas IMM focuses on the resources and risks associated with International Space Station (ISS) and Low Earth Orbit (LEO) missions, IMPACT estimates the frequency and consequences of medical conditions that might arise during exploration missions. One of the services offered by IMM is a series of generic or baseline medical systems associated with typical mission types or DRMs (Design Reference Missions), such that requestors may prioritize questions pertaining to the mission itself over the medical supplies indicated by the model outputs for that DRM. In a mission focused request, the appropriate baseline medical system is used in place of a prepared or optimized medical kit. In preparation, an effort was undertaken to create baseline systems of medical resources within IMPACT suitable for typical DRMs. Using an existing baseline medical system within IMM’s Integrated Medical Evidence Database (iMED) as a starting point, the resources found within the medical kit were compared to and substituted for equivalent resources available within the IMPACT MD (Medical Database). In consultation with clinicians with knowledge of IMPACT’s MD, each resource was matched as closely as possible to a similarly purposed resource in IMPACT, seeking to preserve the treatment capabilities and procedures offered by the IMM medical system while reconciling the differences in modeled resources and medical conditions between the models. To demonstrate the efficacy of this work, a prototype ISS medical system in IMPACT was translated from the baseline used in the IMM. The appropriate medical system was then run through its associated medical model to compare and validate the resultant risks and risk mitigation provided by each baseline ISS medical kit.

S Schwartz↗

ECP Bone Workshop Day 2, Session 1: Validation of Exercise Countermeasures

The thesis of this session of the ECP Bone workshop is that computer modeling is required in order to evaluate factor of risk for fracture when considering the uniquely localized bone loss conditions experienced by Astronauts. This session provides an opportunity to introduce the Integrated Medical Model Bone Fracture Risk (IMM-BFxRM) simulation approach and how this and other models improve understanding of the effects of exercise countermeasures. This workshop session also provides an opportunity for the panel to provide recommendations on this and other "complex modeling" approaches, as well as, the importance of funding the IMM-BFxRM and companion efforts by external scientists (Lang and Keyak).

Myers, Jerry G.↗