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.