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B. Burian

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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.

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CLINICAL DECISION SUPPORT: PATH TO FUNCTIONAL REQUIREMENTS

Long-duration, deep-space exploration missions present significant challenges to crew health and performance. These challenges include the individual and combined effects of microgravity, radiation exposure, isolation, limited resources (mass, volume, power, data and crew time), limited options for evacuation and those associated with delayed or constrained communications, all of which demand greater crew autonomy. Specifically, as the communication delays intensify the further we explore space, the unqualified need for Earth-independent medical operations focused on autonomous diagnosis, treatment and prevention will be key to mission continuation and success. To augment the requisite knowledge, skills and abilities (KSAs) of a time-constrained crew operating under stressful conditions, combatting fatigue, and facing a potential medical crisis, a robust clinical decision support system (CDSS) is a probable solution that would facilitate, guide and inform Earth-independent medical operations, while assisting crewmembers through various clinical presentations. The Exploration Medical Capability (ExMC) Element of the Human Research Program (HRP) is expanding the boundaries of space medical systems to advance the care of astronauts on future exploration missions beyond low Earth orbit. ExMC is actively identifying and testing next-generation medical care and crew health maintenance technologies. The Clinical Decision Support (CDS) project addresses gap Medical-701 within the Inflight Medical Conditions risk: “Enhance medical capabilities within an exploration medical system.” Though mass, volume, and power will face increasing constraints, the projected computational capabilities of spacecraft systems will increase exponentially as information technology continues to advance this decade and beyond. Hence, data, software and computational resources will play an essential and synergistic role in maintaining crew health, wellness and performance in deep space missions. The focus of the CDS project is to develop recommended requirements for an in-vehicle CDSS that acts as a ‘virtual assistant’ for delivering optimal health, performance and medical care during exploration missions. The CDSS is envisioned as an integrated, software-based tool deployed on a laptop computer or handheld device. The CDSS will assist the crew and ground support when interacting with knowledge/databases (e.g. records, pharmacy, schedule), instrumentation (e.g. imaging, physiological monitoring devices), and habitat (e.g. wellness system, task performance system) and vehicle systems (e.g. environmental system, communication system). In addition, the human interface will employ a context-based approach that accounts for the crew’s situation. Thus, extraneous and clinically/operationally non-relevant information are reduced to avoid an increase in cognitive load. The framework of an ideal spaceflight CDSS is to include core and advanced analytical features that incorporate work from collaborators yet maintain a flexible platform for integrating new technology in the future. In fiscal year 2021 (FY21), the CDS project identified requirements through two primary mechanisms: (i) the development of software implementation prototypes and (ii) the application of systems engineering processes. The CDS project developed and tested a series of increasingly complex system prototypes that were based on use cases derived from the CDSS concept of operations (ConOps). These software implementations yielded insights on CDSS functionality as well as lessons learned that provided the initial requirements for CDSS capability. By applying a systems engineering (SE) approach, medical scenarios provided in the ConOps and the use cases for software implementation underwent functional decomposition to identify CDSS functionality. Also, systems-based modeling language (SysML) tools such as activity diagrams were developed from the same ConOps and use cases to identify CDSS functionality. The lessons learned from software implementation defined both specific requirements and broad areas of requirements. Within these defined broad requirement areas, further analysis of the SE products identified specific capability that resulted in the final functional requirements. In summary, the software prototypes, functional decomposition of the ConOps and use cases, and SysML diagrams provided the basis for the CDSS requirements developed in FY21. In the upcoming year, these requirements will be refined for their final ExMC baseline review in latter FY22.

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Clinical Decision Support Project

As NASA plans for exploration missions into deep space, significant challenges are realized due to the distance from Earth. Beside the effects of microgravity and radiation exposure, the astronauts face the additional constraints of isolation, lack of resupply, increasingly difficult evacuation, and delayed and disrupted communication with ground-based medical care providers. These constraints require a paradigm shift from current medical care where crews rely on the real-time communications with ground-based medical care providers toward Earth-independent medical operations for astronaut medical care. Medical expertise and decision-making are ground-based for current International Space Station and planned Lunar missions. However, a deep space exploration crew will need to autonomously perform the detection, diagnosis, treatment, and prevention of medical conditions. One approach to provide Earth-independent medical operations is to augment the requisite knowledge, skills, and abilities (KSAs) of a time-constrained crew—operating under stressful conditions, combatting fatigue, and facing a potential medical crisis—with a robust clinical decision support system (CDSS). The CDSS is envisioned as an integrated, software-based tool deployed on a laptop computer or handheld device. The CDSS will assist the crew and ground support when interacting with knowledge/data bases (e.g. records, pharmacy, schedule), instrumentation (e.g. imaging, physiological monitoring devices), and habitat (e.g. wellness system, task performance system) and vehicle systems (e.g. environmental system, communication system). In addition, the human interface will employ a context-based approach that accounts for the crew’s situation. Thus, extraneous and clinically/operationally non-relevant information are reduced to avoid an increase in cognitive load. The framework of an ideal spaceflight CDSS is to include core and advanced analytical features that maintain a flexible platform for integrating new technology in the future. The Exploration Medical Capability (ExMC) Element of the Human Research Program (HRP) is expanding the boundaries of space medical systems to advance the care of astronauts on future exploration missions beyond low Earth orbit by actively identifying and testing next-generation medical care and crew health maintenance technologies. The Clinical Decision Support (CDS) project addressed ap Medical-701 within the Inflight Medical Conditions risk: “We need to increase inflight medical capabilities and identify new capabilities that (a) maximize benefit and/or (b) reduce “costs” on human system/mission/vehicle resources.” Though mass, volume, and power will face increasing constraints, the projected computational capabilities of spacecraft systems will increase exponentially as information technology advances in this decade and beyond. Hence, data, software, and computational resources will play an essential and synergistic role in maintaining crew health, wellness, and performance in deep space missions. The focus of the CDS project was to develop recommended requirements for an in-vehicle CDSS that acts as a ‘virtual assistant’ for delivering optimal health, performance, and medical care during exploration missions. In fiscal year 2022 (FY22), the CDS project was chartered to baseline and/or revise all CDS project related documentation and update the CDS project model to include the revised CDSS Concept of Operations, revised systems-based modeling language (SysML) activity diagrams, and baseline requirements. The focus of this presentation will be an overview of the CDS products and CDS model content.

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