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Concept of Operations Evaluation for Mitigating Space Flight-Relevant Medical Issues in a Planetary Habitat

Introduction: Analogue environments assist the NASA Human Research Program (HRP) in developing capabilities to mitigate high risk issues to crew health and performance for space exploration. The Habitat Demonstration Unit (HDU) is an analogue habitat used to assess space-related products for planetary missions. The Exploration Medical Capability (ExMC) element at the NASA Johnson Space Center (JSC) was tasked with developing planetary-relevant medical scenarios to evaluate the concept of operations for mitigating medical issues in such an environment. Methods: Two medical scenarios were conducted within the simulated planetary habitat with the crew executing two space flight-relevant procedures: Eye Examination with a corneal injury and Skin Laceration. Remote guidance for the crew was provided by a flight surgeon (FS) stationed at a console outside of the habitat. Audio and video data were collected to capture the communication between the crew and the FS, as well as the movements of the crew executing the procedures. Questionnaire data regarding procedure content and remote guidance performance also were collected from the crew immediately after the sessions. Results: Preliminary review of the audio, video, and questionnaire data from the two scenarios conducted within the HDU indicate that remote guidance techniques from an FS on console can help crew members within a planetary habitat mitigate planetary-relevant medical issues. The content and format of the procedures were considered concise and intuitive, respectively. Discussion: Overall, the preliminary data from the evaluation suggest that use of remote guidance techniques by a FS can help HDU crew execute space exploration-relevant medical procedures within a habitat relevant to planetary missions, however further evaluations will be needed to implement this strategy into the complete concept of operations for conducting general space medicine within similar environments

Barsten, Kristina↗

Exploration Medical System Demonstration (EMSD) Project

The Exploration Medical System Demonstration (EMSD) is a project under the Exploration Medical Capability (ExMC) element managed by the Human Research Program (HRP). The vision for the EMSD is to utilize ISS as a test bed to show that several medical technologies needed for an exploration mission and medical informatics tools for managing evidence and decision making can be integrated into a single system and used by the on-orbit crew in an efficient and meaningful manner. Objectives: a) Reduce and even possibly eliminate the time required for on-orbit crew and ground personnel (which include Surgeon, Biomedical Engineer (BME) Flight Controller, and Medical Operations Data Specialist) to access and move medical data from one application to another. b) Demonstrate that the on-orbit crew has the ability to access medical data/information using an intuitive and crew-friendly software solution to assist/aid in the treatment of a medical condition. c) Develop a common data management framework and architecture that can be ubiquitously used to automate repetitive data collection, management, and communications tasks for all crew health and life sciences activities.

Chin, Duane↗

Prioritizing Medical Resources for Exploration Missions

Long duration missions beyond low Earth orbit introduce new constraints to the medical system. Factors such as the inability to evacuate to Earth in a timely manner, communication delay, limitations in available medical equipment, and the clinical background of the crew will all have an impact on the assessment and treatment of medical conditions. The Exploration Medical Capability (ExMC) Element of NASAs Human Research Program seeks to improve the way the element derives its mitigation strategies for the risk of "Unacceptable Health and Mission Outcomes Due to Limitation of In‐flight Medical Capabilities."

Shah, R. V.↗

Exploration Laboratory Analysis

The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability for manned exploration missions. Since a single, compact space-ready laboratory analysis capability to perform all exploration clinical measurements is not commercially available, the ELA project objective is to demonstrate the feasibility of emerging operational and analytical capability as a biomedical diagnostics precursor to long duration manned exploration missions. The initial step towards ground and flight demonstrations in fiscal year (FY) 2015 was the downselection of platform technologies for demonstrations in the space environment. The technologies selected included two Small Business Innovation Research (SBIR) performers: DNA Medicine Institute's rHEALTH X and Intelligent Optical System's lateral flow assays combined with Holomic's smartphone analyzer. The selection of these technologies were based on their compact size, breadth of analytical capability and favorable ability to process fluids in a space environment, among several factors. These two technologies will be advanced to meet ground and flight demonstration success criteria and requirements. The technology demonstrations and metrics for success will be finalized in FY16. Also, the downselected performers will continue the technology development phase towards meeting prototype deliverables in either late 2016 or 2017.

In-Flight laboratory↗

Exploration Laboratory Analysis

The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability for manned exploration missions. Since a single, compact space-ready laboratory analysis capability to perform all exploration clinical measurements is not commercially available, the ELA project objective is to demonstrate the feasibility of emerging operational and analytical capability as a biomedical diagnostics precursor to long duration manned exploration missions. The initial step towards ground and flight demonstrations in fiscal year (FY) 2015 was the down selection of platform technologies for demonstrations in the space environment. The technologies selected included two Small Business Innovation Research (SBIR) performers: DNA Medicine Institutes rHEALTH X and Intelligent Optical Systems later flow assays combined with Holomics smartphone analyzer. The selection of these technologies were based on their compact size, breadth of analytical capability and favorable ability to process fluids in a space environment, among several factors. These two technologies will be advanced to meet ground and flight demonstration success criteria and requirements that will be finalized in FY16. Also, the down selected performers will continue the technology development phase towards meeting prototype deliverables in either late 2016 or 2017.

Laboratory analysis↗

Exploration Clinical Decision Support System: Medical Data Architecture

The Exploration Clinical Decision Support (ECDS) System project is intended to enhance the Exploration Medical Capability (ExMC) Element for extended duration, deep-space mission planning in HRP. A major development guideline is the Risk of "Adverse Health Outcomes & Decrements in Performance due to Limitations of In-flight Medical Conditions". ECDS attempts to mitigate that Risk by providing crew-specific health information, actionable insight, crew guidance and advice based on computational algorithmic analysis. The availability of inflight health diagnostic computational methods has been identified as an essential capability for human exploration missions. Inflight electronic health data sources are often heterogeneous, and thus may be isolated or not examined as an aggregate whole. The ECDS System objective provides both a data architecture that collects and manages disparate health data, and an active knowledge system that analyzes health evidence to deliver case-specific advice. A single, cohesive space-ready decision support capability that considers all exploration clinical measurements is not commercially available at present. Hence, this Task is a newly coordinated development effort by which ECDS and its supporting data infrastructure will demonstrate the feasibility of intelligent data mining and predictive modeling as a biomedical diagnostic support mechanism on manned exploration missions. The initial step towards ground and flight demonstrations has been the research and development of both image and clinical text-based computer-aided patient diagnosis. Human anatomical images displaying abnormal/pathological features have been annotated using controlled terminology templates, marked-up, and then stored in compliance with the AIM standard. These images have been filtered and disease characterized based on machine learning of semantic and quantitative feature vectors. The next phase will evaluate disease treatment response via quantitative linear dimension biomarkers that enable image content-based retrieval and criteria assessment. In addition, a data mining engine (DME) is applied to cross-sectional adult surveys for predicting occurrence of renal calculi, ranked by statistical significance of demographics and specific food ingestion. In addition to this precursor space flight algorithm training, the DME will utilize a feature-engineering capability for unstructured clinical text classification health discovery. The ECDS backbone is a proposed multi-tier modular architecture providing data messaging protocols, storage, management and real-time patient data access. Technology demonstrations and success metrics will be finalized in FY16.

Biomedical support↗

Medical System Concept of Operations for Mars Exploration Missions

Future exploration missions will be the first time humanity travels beyond Low Earth Orbit (LEO) since the Apollo program, taking us to cis-lunar space, interplanetary space, and Mars. These long-duration missions will cover vast distances, severely constraining opportunities for emergency evacuation to Earth and cargo resupply opportunities. Communication delays and blackouts between the crew and Mission Control will eliminate reliable, real-time telemedicine consultations. As a result, compared to current LEO operations onboard the International Space Station, exploration mission medical care requires an integrated medical system that provides additional in-situ capabilities and a significant increase in crew autonomy. The Medical System Concept of Operations for Mars Exploration Missions illustrates how a future NASA Mars program could ensure appropriate medical care for the crew of this highly autonomous mission. This Concept of Operations document, when complete, will document all mission phases through a series of mission use case scenarios that illustrate required medical capabilities, enabling the NASA Human Research Program (HRP) Exploration Medical Capability (ExMC) Element to plan, design, and prototype an integrated medical system to support human exploration to Mars.

Urbina, M.↗

Defining Medical Levels of Care for Exploration Missions

NASA medical care standards establish requirements for providing health and medical programs for crewmembers during all phases of a mission. These requirements are intended to prevent or mitigate negative health consequences of long-duration spaceflight, thereby optimizing crew health and performance over the course of the mission. Current standards are documented in the two volumes of the NASA-STD-3001 Space Flight Human-System Standard document, established by the Office of the Chief Health and Medical Officer. Its purpose is to provide uniform technical standards for the design, selection, and application of medical hardware, software, processes, procedures, practices, and methods for human-rated systems. NASA-STD-3001 Vol. 1 identifies five levels of care for human spaceflight. These levels of care are accompanied by several components that illustrate the type of medical care expected for each. The Exploration Medical Capability (ExMC) of the Human Research Program has expanded the context of these provided levels of care and components. This supplemental information includes definitions for each component of care and example actions that describe the type of capabilities that coincide with the definition. This interpretation is necessary in order to fully and systematically define the capabilities required for each level of care in order to define the medical requirements and plan for infrastructure needed for medical systems of future exploration missions, such as one to Mars.

Hailey, M.↗

Medical System Concept of Operations for Mars Exploration Missions

Future exploration missions will be the first time humanity travels beyond Low Earth Orbit (LEO) since the Apollo program, taking us to cis-lunar space, interplanetary space, and Mars. These long-duration missions will cover vast distances, severely constraining opportunities for emergency evacuation to Earth and cargo resupply opportunities. Communication delays and blackouts between the crew and Mission Control will eliminate reliable, real-time telemedicine consultations. As a result, compared to current LEO operations onboard the International Space Station, exploration mission medical care requires an integrated medical system that provides additional in-situ capabilities and a significant increase in crew autonomy. The Medical System Concept of Operations for Mars Exploration Missions illustrates how a future NASA Mars program could ensure appropriate medical care for the crew of this highly autonomous mission. This Concept of Operations document, when complete, will document all mission phases through a series of mission use case scenarios that illustrate required medical capabilities, enabling the NASA Human Research Program (HRP) Exploration Medical Capability (ExMC) Element to plan, design, and prototype an integrated medical system to support human exploration to Mars.

Urbina, Michelle↗

Medical Simulations for Exploration Medicine

Medical simulation is a useful tool that can be used to train personnel, develop medical processes, and assist cross-disciplinary communication. Medical simulations have been used in the past at NASA for these purposes, however they are usually created ad hoc. A stepwise approach to scenario development has not previously been used. The NASA Exploration Medical Capability (ExMC) created a medical scenario development tool to test medical procedures, technologies, concepts of operation and for use in systems engineering (SE) processes.

Reyes, David↗

Exploration Medical System Trade Study Tools Overview

ExMC is creating an ecosystem of tools to enable well-informed medical system trade studies. The suite of tools address important system implementation aspects of the space medical capabilities trade space and are being built using knowledge from the medical community regarding the unique aspects of space flight. Two integrating models, a systems engineering model and a medical risk analysis model, tie the tools together to produce an integrated assessment of the medical system and its ability to achieve medical system target requirements. This presentation will provide an overview of the various tools that are a part of the tool ecosystem. Initially, the presentation's focus will address the tools that supply the foundational information to the ecosystem. Specifically, the talk will describe how information that describes how medicine will be practiced is captured and categorized for efficient utilization in the tool suite. For example, the talk will include capturing what conditions will be planned for in-mission treatment, planned medical activities (e.g., periodic physical exam), required medical capabilities (e.g., provide imaging), and options to implement the capabilities (e.g., an ultrasound device). Database storage and configuration management will also be discussed. The presentation will include an overview of how these information tools will be tied to parameters in a Systems Modeling Language (SysML) model, allowing traceability to system behavioral, structural, and requirements content. The discussion will also describe an HRP-led enhanced risk assessment model developed to provide quantitative insight into each capability's contribution to mission success. Key outputs from these various tools, to be shared with the space medical and exploration mission development communities, will be assessments of medical system implementation option satisfaction of requirements and per-capability contributions toward achieving requirements.

Mindock, J.↗

Exploration Medical Capability Medical System Recommendations for Gateway

- Medical System Content Development - 2019: Develop clinical content to inform medical system design; Iterate on content with wider ExMC (Exploration Medical Capability) team; Capture processes used to perform these tasks. - Using model content to inform system design - SME (Subject Matter Expert) collaboration to refine systems using clinical content.

Hailey, Melinda↗

Development of an Accepted Medical Condition List for Exploration Medical Capability Scoping

The Accepted Medical Conditions List (AMCL) is a product designed to provide a traceable, repeatable, evidence-based consensus process for scoping the medical capability needs for future design reference missions (DRMs) and upcoming programs. These include a Mars transit DRM and a shorter duration cis-lunar DRM. The development of a baseline AMCL by the Exploration Medical Capability (ExMC) Element will assist the effort to identify high priority medical capabilities for inclusion in mission and vehicle planning and provide traceable and documented clinical needs to the Systems Engineering teams tasked with requirements development and design work.

Medical Condition List↗

Developing a Medical System Foundation for Level of Care IV: Short-Duration Lunar Orbit

The Human Research Program (HRP) Exploration Medical Capability (ExMC) element has developed a Medical System Foundation for Level of Care IV, as defined by NASA’s space flight human-system standards, for short-duration lunar orbit missions by employing a systems engineering approach using model-based systems engineering tools. This Foundation includes a concept of operations, medical system architecture, associated functional and non-functional requirements and rationales, and medical conditions, capabilities, and resources. Collectively, these serve as a starting point (“Foundation”) for a medical system that meets the Level of Care IV requirement. The Foundation also includes traces to the current versions of NASA standards documents and lower (e.g., sub-system) and higher (e.g., vehicle system) level requirements. Stakeholders can use the Foundation to analyze the traces between medical capabilities, medical conditions, medical resources, and requirements; identify medical system interfaces with other vehicle systems/subsystems; and as a basis for performing trades on risks vs. medical system mass and volume allocation. To facilitate communication of the Foundation to stakeholders who do not have access to the modeling tools used, an HTML representation of the Foundation was created. This discussion will focus on the processes through which the Medical System Foundation was developed, how the Foundation builds a bridge between the medical and engineering domains and facilitates communication between these communities, and how these processes can be applied more broadly to a crew health and performance system and other system domains.

S. Lumpkins↗

Exploration Medical Capability Science and Research Overview and Update

The mission of the Exploration Medical Capability (ExMC) Element is to advance medical system design and risk-informed decision making for exploration beyond low Earth orbit to promote human health and performance in space. In order to accomplish this mission, the Element takes a progressively Earth-independent approach to three main areas: 1)answering key clinical and science research questions that will help to address the challenges of providing medical care in the extreme environment of space, 2)applying systems engineering processes to medical system design with the goal of developing robust requirements that can be fully integrated into future space exploration vehicle designs, and 3)developing and demonstrating novel medical technologies that will improve future medical capabilities in space. This presentation will focus on selected scientific and technical conceptual drivers for the Element, the current and future research risks and gaps, and provide an overview of the Element’s progress in 2020.

Kris Lehnhardt↗

Clinical Decision Support - Concepts of Operation

We are entering a new era in space exploration to return to the moon and explore Mars. Crew members operating independently during long duration space exploration missions will require a clinical decision support system (CDSS) to increase autonomy by augmenting their knowledge, skills and abilities in different scenarios. Significant changes to in-flight and habitat medical care due to constraints on mass, volume, power, crew time and medical evacuation capabilities are needed to increase crew autonomy and self-reliance in decision making and task performance. The Exploration Medical Capability (ExMC) Element of the Human Research Program (HRP) pushes the boundary of space medical systems to advance the care of astronauts on future exploration missions beyond low Earth orbit by identifying and testing next-generation medical care and crew health maintenance technologies. Clinical decision support (CDS) presents knowledge and data in a context aware manner to augment a crew members’ knowledge, skills and abilities during the process of observation, orientation, decisions and action. A comprehensive crew health and performance CDSS is required to augment crew capability and will be used in different scenarios for several reasons. In general, the CDSS’s role is to assist the crew in prevention, detection, diagnosis and treatment of crew health and performance related conditions that may arise in exploration spaceflight. For example, CDSS would assist a high acuity scenario such as a heart attack by supplying clear instructions, vital signs and treatment reminders. A lower severity scenario such as kidney stone risk could interface to vehicle systems and display more complex predictive data during a diagnosis. A CDSS needs to contribute to successful missions by maintaining a high performing crew who can potentially exhibit countless medical conditions related to derangements from the space environment (sleep, cognition, nutrition and exercise) as well as conditions intrinsic to humans anywhere. While supporting the crew’s ability to make sound clinical decisions is desirable in any mission, it is essential for exploration missions with significant communication delays, no evacuation capability, and extended exposure to the flight environment. Such missions correspond with medical Level of Care V (LOC V), the highest level specified in NASA-STD-3001. The project focuses on CDS implementation research to derive requirements for LOC V, where the need for increased autonomy results in new practices and the inclusion of non-clinical data, such as vehicle environmental measures and physical exercise results, from other human and vehicle domains and advanced analytics. The CDS project describes how the CDSS is intended to be used by defining concepts of operations (ConOps). The process to derive ConOps focuses on increased autonomy that reduces the likelihood and consequences of accepted medical conditions. These crew health and performance inputs are grouped by common datasets and analysis models. Use cases are derived to research new clinical scenarios, architectural development and workflows. Implementation research is conducted with protypes to inform assumptions and derive requirements. The project also establishes how externally developed analysis and approaches can be added to expand a clinical decision support system and thus highlight how a comprehensive system can be globally developed with collaborators. This presentation will cover example scenarios from the CDS ConOps and the method to derive them. One example scenario will be CDSS alerting an increased kidney stone risk during a mission, with diagnosis and treatment options provided during the intervention.

clinical decision support↗

Market Survey 2020: Commercial Clinical Decision Support Systems and Wellness Tools

For long-duration, deep space exploration missions, current methods for managing and supporting crew health and medical conditions will be unsuitable. Communication and data transmission lags will necessitate the use of a sophisticated clinical decision support system (CDSS) that will tailor diagnosis and treatment guidance that is context-sensitive for anticipated astronaut health, wellness, and medical conditions. A variety of clinical decision support (CDS) and wellness tools (WT) are currently available in the commercial market and a broad-brush survey of this market can provide an initial impression of the current state of the art which, in turn, can inform the roadmap of NASA deep space CDSS development and associated requirements. Such a survey was undertaken during the first six months of 2020 using directed convenience sampling to obtain information provided by vendors on their websites; both commercially available CDS and WT (such as those used to track and monitor nutrition, exercise, and sleep) were included. Areas assessed were item type (e.g., software/application, device); primary purpose of the item (e.g., diagnostic support, nutrition tracking); additional purposes (if any); reported features, capabilities, and functionality; setting of use (e.g., inpatient, outpatient); intended user (e.g., clinician, patient); location and sources of data/information used or produced by the item; integration with patient electronic health record (EHR); compliance with interoperability ontologies and standards (e.g., Health Level 7 [HL7], Systematized Nomenclature of Medicine – Clinical Terminology [SNOMED-CT]); and whether the item is knowledge-based (derived from research findings) or non-knowledge-based (derived through artificial intelligence, machine learning, advanced probability and statistics), among others. Ninety-seven (97) vendor websites describing 196 CDS and 73 WT (269 total) were reviewed and coded. The primary purpose of the majority of CDS reviewed is diagnosis or diagnosis/treatment/drug decision support—targeted for clinician use— and the primary purpose of the majority of WT reviewed is the monitoring of different health metrics, most often through the use of a biosensor device (e.g., blood pressure)—targeted for patient use. Very few CDS or WT appear to comply with major international interoperability standards or can be integrated with a patient’s EHR data. None consider contextual factors, such as conditions of the physical environment (e.g., CO2 levels). The majority of CDS and WT reviewed are non-knowledge, cloud- or web-based applications or software. Forty-three (43) major findings were identified and the implications those findings have for NASA will be discussed. Example major findings include: CDS-WT capabilities range from diagnosis to treatment applications, CDS-WT may be wearable or non-wearable and are technologically advanced and only a few CDS-WT tools referenced compliance to ensure interoperability, among other findings. Recommendations will also be offered that will help to address ExMC Gap, Medical-701: Enhance medical capabilities within an exploration medical system.

market survey↗

Clinical Decision Support - Concepts of Operation

We are entering a new era in space exploration to return to the moon and explore Mars. Crew members operating independently during long duration space exploration missions will require a clinical decision support system (CDSS) to increase autonomy by augmenting their knowledge, skills and abilities in different scenarios. Significant changes to in-flight and habitat medical care due to constraints on mass, volume, power, crew time and medical evacuation capabilities are needed to increase crew autonomy and self-reliance in decision making and task performance. The Exploration Medical Capability (ExMC) Element of the Human Research Program (HRP) pushes the boundary of space medical systems to advance the care of astronauts on future exploration missions beyond low Earth orbit by identifying and testing next-generation medical care and crew health maintenance technologies. Clinical decision support (CDS) presents knowledge and data in a context aware manner to augment a crew members’ knowledge, skills and abilities during the process of observation, orientation, decisions and action. A comprehensive crew health and performance CDSS is required to augment crew capability and will be used in different scenarios for several reasons. In general, the CDSS’s role is to assist the crew in prevention, detection, diagnosis and treatment of crew health and performance related conditions that may arise in exploration spaceflight. For example, CDSS would assist a high acuity scenario such as a heart attack by supplying clear instructions, vital signs and treatment reminders. A lower severity scenario such as kidney stone risk could interface to vehicle systems and display more complex predictive data during a diagnosis. A CDSS needs to contribute to successful missions by maintaining a high performing crew who can potentially exhibit countless medical conditions related to derangements from the space environment (sleep, cognition, nutrition and exercise) as well as conditions intrinsic to humans anywhere. While supporting the crew’s ability to make sound clinical decisions is desirable in any mission, it is essential for exploration missions with significant communication delays, no evacuation capability, and extended exposure to the flight environment. Such missions correspond with medical Level of Care V (LOC V), the highest level specified in NASA-STD-3001. The project focuses on CDS implementation research to derive requirements for LOC V, where the need for increased autonomy results in new practices and the inclusion of non-clinical data, such as vehicle environmental measures and physical exercise results, from other human and vehicle domains and advanced analytics. The CDS project describes how the CDSS is intended to be used by defining concepts of operations (ConOps). The process to derive ConOps focuses on increased autonomy that reduces the likelihood and consequences of accepted medical conditions. These crew health and performance inputs are grouped by common datasets and analysis models. Use cases are derived to research new clinical scenarios, architectural development and workflows. Implementation research is conducted with protypes to inform assumptions and derive requirements. The project also establishes how externally developed analysis and approaches can be added to expand a clinical decision support system and thus highlight how a comprehensive system can be globally developed with collaborators. This presentation will cover example scenarios from the CDS ConOps and the method to derive them. One example scenario will be CDSS alerting an increased kidney stone risk during a mission, with diagnosis and treatment options provided during the intervention.

clinical decision support↗