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NASA NTRS2018

The Pathway to a Safe and Effective Spaceflight Medication Formulary: Expert Review Panel Recommendations

Exploration spaceflight poses several challenges to the provision of a comprehensive medication formulary. This formulary must accommodate the size and space limitations of the spacecraft, while addressing individual medication needs and preferences of the crew, consequences of a degrading inventory over time, the inability to resupply used or expired medications, and the need to forecast the best possible medication candidates to treat conditions that may occur. The Exploration Medical Capability (ExMC) Element's Pharmacy Project Team has developed a research plan (RP) that is focused on evidence-based models and theories as well as new diagnostic tools, treatments, or preventive measures aimed to ensure an available, safe, and effective pharmacy sufficient to manage potential medical threats during exploration spaceflight. Here, we will discuss the ways in which the ExMC Pharmacy Project Team pursued expert evaluation and guidance, and incorporated acquired insight into an achievable research pathway, reflected in the revised RP.

Daniels, V. R.↗

NASA NTRSDate not supplied

Summary of Technical Interchange Meetings (TIMs) Designed to Enable Earth Independent Medical Operations (EIMO)

The Exploration Medical Capability Element (ExMC) in NASA’s Human Research Program hosted a series of TIMs in 2023-2024 designed to stimulate discussion around specific topics with the goal of enabling EIMO. In context of the thematic constituent elements of EIMO, namely pre-mission planning, acute/emergent/prolonged medical decision making, supply/resource management and task load management, subject matter experts from industry, academia and government (NASA and other Agencies) provided valuable and actionable guidance and recommendations. Earth-based medical experts will remain indispensable for pre-mission planning, however, management of acute/emergent medical contingencies will require a gradual transition of medical care and decision making from terrestrial to space-based assets to enable support of astronaut health and performance and reduce overall mission risk. Key to achieving these enhancements is providing an integrated data system platform capable of utilizing multiple data streams in concert with a variety of on-board databases and passive monitoring of video and wearable sensors to enable a multi-modal, agentic AI-based clinical decision support system (CDSS) to support crew medical officer (CMO) medical decision-making. The EIMO series of TIMs (I-V) have proven to be instructive and portend a significant paradigm shift will be necessary to maintain crew health and performance on exploration class missions. Importantly, since the expected paradigm shift will be significantly different from the methods of operation that have been employed for the majority of missions from the inception of human spaceflight to date, any proposed methods must be deployed in the setting of ongoing operations early and be “tested, reviewed and practiced” while reliable back-up is available to facilitate an Enterprise-wide level of comfort and acceptance. Serious constraints on data transmission coupled with a large and expanding universe of on-board medical informatics data streams will necessitate implementation of a CDSS to supplant the current reliance on support provided by ground-based SMEs. Establishment of trust in the system by CMO/crew and the ground-based medical support team will be essential. Co-development of a CDSS with industry partners will assure that state of the art tools can be employed, and industry efficiencies can be leveraged. Training regimens, materials and tools must evolve to be responsive (just-in-time training) and facilitate autonomous execution of procedures. Proficiency metrics should be established and be based on validated competencies or milestones as opposed to a prescribed number of training hours. Training should be prioritized for broad, translatable skills that have universal application across a variety of medical conditions. Repetition was deemed to be the key to achieving proficiency and emphasis should lie in procedural training which is known to extinguish more rapidly than diagnostic skills. Advanced tools, e.g., extended reality, can provide more realistic and effective training. Use of advanced probabilistic risk assessment tools will be essential to optimize the medical system capability while carefully balancing risk relative to mass/power/volume limitations. Importance of factoring use-life of medical supplies and maintaining awareness of redundancy and opportunity to re-purpose under off nominal situations was emphasized. Consideration of adopting optimized performance standards vs. “good-enough” performance thresholds is warranted. The use of legacy systems as opposed to creating new systems may be preferable. Managing task load and associated cognitive load will be essential to maintain operational safety and behavioral health. ExMC aspires to create a shared EIMO paradigm and strategic vision for advancing medical system design through novel technologies, training, protocols, and support capabilities, built upon the spirit of successful strategies and innovations over the past six decades of space medicine operations.

Jay Lemery↗

NASA NTRS2023

The Value of a Spaceflight Clinical Decision Support System for Earth-Independent Medical Operations

As NASA prepares for crewed lunar missions over the next several years, plans are also underway to journey farther into deep space. Deep space exploration will require a paradigm shift in astronaut medical support toward progressively earth-independent medical operations (EIMO). The Exploration Medical Capability (ExMC) element of NASA’s Human Research Program (HRP) is investigating the feasibility and value of advanced capabilities to promote and enhance EIMO. Currently, astronauts rely on real-time communication with ground-based medical providers. However, as the distance from Earth increases, so do communication delays and disruptions. Moreover, resupply and evacuation will become increasingly complex, if not impossible, on deep space missions. In contrast to today’s missions in low earth orbit (LEO), where most medical expertise and decision-making are ground-based, an exploration crew will need to autonomously detect, diagnose, treat, and prevent medical events. Due to the sheer amount of pre-mission training required to execute a human spaceflight mission, there is often little time to devote exclusively to medical training. One potential solution is to augment the long duration exploration crew’s knowledge, skills, and abilities with a clinical decision support system (CDSS). An analysis of preliminary data indicates the potential benefits of a CDSS to mission outcomes when augmenting cognitive and procedural performance of an autonomous crew performing medical operations, and we provide an illustrative scenario of how such a CDSS might function.

Brian K. Russell↗

NASA NTRS2012

Bayesian Analysis for Risk Assessment of Selected Medical Events in Support of the Integrated Medical Model Effort

The Exploration Medical Capability project is creating a catalog of risk assessments using the Integrated Medical Model (IMM). The IMM is a software-based system intended to assist mission planners in preparing for spaceflight missions by helping them to make informed decisions about medical preparations and supplies needed for combating and treating various medical events using Probabilistic Risk Assessment. The objective is to use statistical analyses to inform the IMM decision tool with estimated probabilities of medical events occurring during an exploration mission. Because data regarding astronaut health are limited, Bayesian statistical analysis is used. Bayesian inference combines prior knowledge, such as data from the general U.S. population, the U.S. Submarine Force, or the analog astronaut population located at the NASA Johnson Space Center, with observed data for the medical condition of interest. The posterior results reflect the best evidence for specific medical events occurring in flight. Bayes theorem provides a formal mechanism for combining available observed data with data from similar studies to support the quantification process. The IMM team performed Bayesian updates on the following medical events: angina, appendicitis, atrial fibrillation, atrial flutter, dental abscess, dental caries, dental periodontal disease, gallstone disease, herpes zoster, renal stones, seizure, and stroke.

Gilkey, Kelly M.↗

NASA NTRS2017

Risk of Adverse Health Outcomes and Decrements in Performance Due to In-flight Medical Conditions

The drive to undertake long-duration space exploration missions at greater distances from Earth gives rise to many challenges concerning human performance under extreme conditions. At NASA, the Human Research Program (HRP) has been established to investigate the specific risks to astronaut health and performance presented by space exploration, in addition to developing necessary countermeasures and technology to reduce risk and facilitate safer, more productive missions in space (NASA Human Research Program 2009). The HRP is divided into five subsections, covering behavioral health, space radiation, habitability, and other areas of interest. Within this structure is the ExMC Element, whose research contributes to the overall development of new technologies to overcome the challenges of expanding human exploration and habitation of space. The risk statement provided by the HRP to the ExMC Element states: "Given that medical conditions/events will occur during human spaceflight missions, there is a possibility of adverse health outcomes and decrements in performance in mission and for long term health" (NASA Human Research Program 2016). Within this risk context, the Exploration Medical Capabilities (ExMC) Element is specifically concerned with establishing evidenced-based methods of monitoring and maintaining astronaut health. Essential to completing this task is the advancement in techniques that identify, prevent, and treat any health threats that may occur during space missions. The ultimate goal of the ExMC Element is to develop and demonstrate a pathway for medical system integration into vehicle and mission design to mitigate the risk of medical issues. Integral to this effort is inclusion of an evidence-based medical and data handling system appropriate for long-duration, exploration-class missions. This requires a clear Concept of Operations, quantitative risk metrics or other tools to address changing risk throughout a mission, and system scoping and system engineering. Because of the novel nature of the risks involved in exploration missions, new and complex ethical challenges are likely to be encountered. This document describes the relevant background and evidence that informs the development of an exploration medical system.

Antonsen,Erik↗

NASA NTRS2011

NASA Human Research Wiki - An Online Collaboration Tool

In preparation for exploration-class missions, the Exploration Medical Capability (ExMC) element of NASA's Human Research Program (HRP) has compiled a large evidence base, which previously was available only to persons within the NASA community. The evidence base is comprised of several types of data, for example: information on more than 80 medical conditions which could occur during space flight, derived from several sources (including data on incidence and potential outcomes of these medical conditions, as captured in the Integrated Medical Model's Clinical Finding Forms). In addition, approximately 35 gap reports are included in the evidence base, identifying current understanding of the medical challenges for exploration, as well as any gaps in knowledge and/or technology that would need to be addressed in order to provide adequate medical support for these novel missions. In an effort to make the ExMC information available to the general public and increase collaboration with subject matter experts within and outside of NASA, ExMC has developed an online collaboration tool, very similar to a wiki, titled the NASA Human Research Wiki. The platform chosen for this data sharing, and the potential collaboration it could generate, is a MediaWiki-based application that would house the evidence, allow "read only" access to all visitors to the website, and editorial access to credentialed subject matter experts who have been approved by the Wiki's editorial board. Although traditional wikis allow users to edit information in real time, the NASA Human Research Wiki includes a peer review process to ensure quality and validity of information. The wiki is also intended to be a pathfinder project for other HRP elements that may want to use this type of web-based tool. The wiki website will be released with a subset of the data described and will continue to be populated throughout the year.

Barr, Y. R.↗

NASA NTRS2023

Progressively Enabling Earth Independent Medical Operations (EIMO)

This panel presents the findings from a series of Technical Interchange Meetings (TIMs) hosted by the Exploration Medical Capability Element (ExMC) in NASA’s Human Research Program. The topics for the TIMs were derived from a 2-day conference of senior leaders and subject matters experts that collectively outlined a multi-faceted strategy designed to optimize crew health and performance through an increasingly autonomous medical approach. The first abstract in this panel outlines the scope of issues related to data collection, usage, transmission and computing capacity to facilitate EIMO. The second presentation provides an overview of the challenges in developing curricula and advanced training tools to baseline knowledge, skills and abilities (KSA), verify clinical competency and assure retention during prolonged durations inherent in exploration-class missions. An overview of the complicated medical supply and resource chain necessary to facilitate EIMO is provided in the third presentation of this panel. The final presentation in this EIMO panel surveys the breadth and depth of demands on cognitive load expected to be experienced by crew on an exploration mission and proposes strategies to mitigate the prospect of cognitive overload through methods to shift task load from the crew to multi-modal artificial intelligence based medical support systems. Taken together, these presentations summarize the challenges to be expected and potential solution spaces to be explored and developed to progressively enable increasing autonomous medical operations to support crewed missions beyond low earth orbit. Through EIMO focused pre-mission planning, integrated data architecture design, innovative training development and AI-assisted task load management, the gradual transition of medical care and decision making from terrestrial to space-based assets enabling support of astronaut health and performance and reducing overall mission risk is achievable.

Jay Lemery↗

NASA NTRSDate not supplied

Progressively Enabling Earth Independent Medical Operations (EIMO)

John Lemery↗

NASA NTRSDate not supplied

Envisioning the Future Role of an Exploration Clinical Decision Support System

The Exploration Medical Capability Element of the NASA Human Research Program seeks to fuse new and existing technologies with practical mission goals into feasible and fiscally realizable human missions to the Moon and Mars. Expected communication delays with Earth-based medical experts will require unprecedented crew self-reliance to rapidly identify and treat anticipated and unforeseen medical conditions using constrained onboard resources with limited crew clinical skill. During this session, the current status of this project will be presented. We will discuss how current modes of decision support (e.g., alerts of critical values, reminders of overdue preventive health tasks, guided clinical workflows, advice for drug prescribing, critiques of existing health care orders, and suggestions for various active care issues) can be tailored to exploration crew needs.

human-system integration↗

NASA NTRS2017

Medical Optimization Network for Space Telemedicine Resources

INTRODUCTION: Long-duration missions beyond low Earth orbit introduce new constraints to the space medical system. Beyond the traditional limitations in mass, power, and volume, consideration must be given to other factors such as the inability to evacuate to Earth, communication delays, and limitations in clinical skillsets. As NASA develops the medical system for an exploration mission, it must have an ability to evaluate the trade space of what resources will be most important. The Medical Optimization Network for Space Telemedicine Resources (MONSTR) was developed over the past year for this reason, and is now a system for managing data pertaining to medical resources and their relative importance when addressing medical conditions. METHODS: The MONSTR web application with a Microsoft SQL database backend was developed and made accessible to Tableau v9.3 for analysis and visualization. The database was initially populated with a list of medical conditions of concern for an exploration mission taken from the Integrated Medical Model (IMM), a probabilistic model designed to quantify in-flight medical risk. A team of physicians working within the Exploration Medical Capability Element of NASA's Human Research Program compiled a list diagnostic and treatment medical resources required to address best- and worst-case scenarios of each medical condition using a terrestrial standard of care and entered this data into the system. This list included both tangible resources (e.g. medical equipment, medications) and intangible resources (e.g. clinical skills required to perform a procedure). The physician team then assigned criticality values to each instance of a resource, representing the importance of that resource to diagnosing or treating its associated condition(s). Medical condition probabilities of occurrence during a Mars mission were pulled from the IMM and imported into the MONSTR database for use within a resource criticality-weighting algorithm. DISCUSSION: The MONSTR tool is a novel approach to assess the relative value of individual resources needed for the diagnosis and treatment of medical conditions. Future work will add resources for prevention and long term care of these conditions. Once data collection is complete, MONSTR will provide the operational and research communities at NASA with information to support informed decisions regarding areas of research investment, future crew training, and medical supplies manifested as part of any exploration medical system.

Rubin, D.↗

NASA NTRS2008

Life Sciences Data Archive (LSDA)

In the early days of spaceflight, space life sciences data were been collected and stored in numerous databases, formats, media-types and geographical locations. While serving the needs of individual research teams, these data were largely unknown/unavailable to the scientific community at large. As a result, the Space Act of 1958 and the Science Data Management Policy mandated that research data collected by the National Aeronautics and Space Administration be made available to the science community at large. The Biomedical Informatics and Health Care Systems Branch of the Space Life Sciences Directorate at JSC and the Data Archive Project at ARC, with funding from the Human Research Program through the Exploration Medical Capability Element, are fulfilling these requirements through the systematic population of the Life Sciences Data Archive. This program constitutes a formal system for the acquisition, archival and distribution of data for Life Sciences-sponsored experiments and investigations. The general goal of the archive is to acquire, preserve, and distribute these data using a variety of media which are accessible and responsive to inquiries from the science communities.

Fitts, M.↗

NASA NTRS2009

Human Research Program Requirements Document (Revision C)

The purpose of this document is to define, document, and allocate the Human Research Program (HRP) requirements to the HRP Program Elements. It establishes the flow-down of requirements from Exploration Systems Mission Directorate (ESMD) and Office of the Chief Health and Medical Officer (OCHMO) to the various Program Elements of the HRP to ensure that human research and technology countermeasure investments are made to insure the delivery of countermeasures and technologies that satisfy ESMD's and OCHMO's exploration mission requirements. Requirements driving the HRP work and deliverables are derived from the exploration architecture, as well as Agency standards regarding the maintenance of human health and performance. Agency human health and performance standards will define acceptable risk for each type and duration of exploration mission. It is critical to have the best available scientific and clinical evidence in setting and validating these standards. In addition, it is imperative that the best available evidence on preventing and mitigating human health and performance risks is incorporated into exploration mission and vehicle designs. These elements form the basis of the HRP research and technology development requirements and highlight the importance of HRP investments in enabling NASA's exploration missions. This PRD defines the requirements of the HRP which is comprised of the following major Program Elements: Behavioral Health and Performance (BHP), Exploration Medical Capability (ExMC), Human Health Countermeasures (HHC), ISS Medical Project (ISSMP), Space Human Factors and Habitability (SHFH), and Space Radiation (SR).

Vargas, Paul R.↗

NASA NTRS2009

Life Sciences Data Archive (LSDA) in the Post-Shuttle Era

Now, more than ever before, NASA is realizing the value and importance of their intellectual assets. Principles of knowledge management, the systematic use and reuse of information/experience/expertise to achieve a specific goal, are being applied throughout the agency. LSDA is also applying these solutions, which rely on a combination of content and collaboration technologies, to enable research teams to create, capture, share, and harness knowledge to do the things they do well, even better. In the early days of spaceflight, space life sciences data were been collected and stored in numerous databases, formats, media-types and geographical locations. These data were largely unknown/unavailable to the research community. The Biomedical Informatics and Health Care Systems Branch of the Space Life Sciences Directorate at JSC and the Data Archive Project at ARC, with funding from the Human Research Program through the Exploration Medical Capability Element, are fulfilling these requirements through the systematic population of the Life Sciences Data Archive. This project constitutes a formal system for the acquisition, archival and distribution of data for HRP-related experiments and investigations. The general goal of the archive is to acquire, preserve, and distribute these data and be responsive to inquiries from the science communities.

Fitts, Mary A.↗

NASA NTRS2010

Life Sciences Data Archives (LSDA) in the Post-Shuttle Era

Now, more than ever before, NASA is realizing the value and importance of their intellectual assets. Principles of knowledge management-the systematic use and reuse of information, experience, and expertise to achieve a specific goal-are being applied throughout the agency. LSDA is also applying these solutions, which rely on a combination of content and collaboration technologies, to enable research teams to create, capture, share, and harness knowledge to do the things they do well, even better. In the early days of spaceflight, space life sciences data were collected and stored in numerous databases, formats, media-types and geographical locations. These data were largely unknown/unavailable to the research community. The Biomedical Informatics and Health Care Systems Branch of the Space Life Sciences Directorate at JSC and the Data Archive Project at ARC, with funding from the Human Research Program through the Exploration Medical Capability Element, are fulfilling these requirements through the systematic population of the Life Sciences Data Archive. This project constitutes a formal system for the acquisition, archival and distribution of data for HRP-related experiments and investigations. The general goal of the archive is to acquire, preserve, and distribute these data and be responsive to inquiries for the science communities. Information about experiments and data, as well as non-attributable human data and data from other species' are available on our public Web site http://lsda.jsc.nasa.gov. The Web site also includes a repository for biospecimens, and a utilization process. NASA has undertaken an initiative to develop a Shuttle Data Archive repository. The Shuttle program is nearing its end in 2010 and it is critical that the medical and research data related to the Shuttle program be captured, retained, and usable for research, lessons learned, and future mission planning. Communities of practice are groups of people who share a concern or a passion for something they do, and learn how to do it better as they interact regularly. LSDA works with the HRP community of practice to ensure that we are preserving the relevant research and data they need in the LSDA repository. An evidence-based approach to risk management is required in space life sciences. Evidence changes over time. LSDA has a pilot project with Collexis, a new type of Web-based search engine. Collexis differentiates itself from full-text search engines by making use of thesauri for information retrieval. The high-quality search is based on semantics that have been defined in a life sciences ontology. Additionally, Collexis' matching technology is unique, allowing discovery of partially matching dicuments. Users do not have to construct a complicated (Boolean) search query, but can simply enter a free text search without the risk of getting "no results". Collexis may address these issues by virtue of its retrieval and discovery capabilities across multiple repositories.

Fitts, Mary A.↗

NASA NTRS2011

An Evidence Based Approach to Designing Medical Support for Long Duration, Interplanetary Missions

The Exploration Medical Capability (ExMC) element is one of six elements under NASA's Human Research Program (HRP). The goal of the ExMC element is to address the risk of the "inability to adequately recognize or treat an ill or injured crewmember." This poster highlights the evidence-based approach that the ExMC element has taken to address this goal, and the ExMC element's current areas of interest.

Watkins, S. D.↗

NASA NTRS2014

Challenges to Health During Deep Space Exploration Missions

Long duration missions outside of low Earth orbit will present unique challenges to the maintenance of human health. Stressors with physiologic and psychological impacts are inherent in exploration missions, including reduced gravity, increased radiation, isolation, limited habitable volume, circadian disruptions, and cabin atmospheric changes. Operational stressors such as mission timeline and extravehicular activities must also be considered, and these varied stressors may act in additive or synergistic fashions. Should changes to physiology or behavior manifest as a health condition, the rendering of care in an exploration environment must also be considered. Factors such as the clinical background of the crew, inability to evacuate to Earth in a timely manner, communication delay, and limitations in available medical resources will have an impact on the assessment and treatment of these conditions. The presentations associated with this panel will address these unique challenges from the perspective of several elements of the NASA Human Research Program, including Behavioral Health and Performance, Human Health Countermeasures, Space Radiation, and Exploration Medical Capability.

Watkins, S.↗

NASA NTRS2015

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.↗

NASA NTRS2016

Review of NASA's Evidence Reports on Human Health Risks

NASA has requested a study from the Institute of Medicine (IOM) to provide an independent review of more than 30 evidence reports on human health risks for long duration and exploration spaceflight. The evidence reports, which are publicly available, are categorized into five broad categories: (1) behavioral health and performance; (2) human health countermeasures (with a focus on bone metabolism and orthopedics, nutrition, immunology, and cardiac and pulmonary physiology); (3) radiation; (4) human factors issues; and (5) exploration medical capabilities. The reports are revised on an ongoing basis to incorporate new scientific information. In conducting this study, an IOM ad hoc committee will build on the 2008 IOM report Review of NASA's Human Research Program Evidence Books. That report provided an assessment of the process used for developing the evidence reports and provided an initial review of the evidence reports that had been completed at that time. Each year, NASA staff will identify a set of evidence reports for committee review. Over the course of the study all evidence reports will be reviewed. The committee will hold an annual scientific workshop to receive input on the evidence reports it is reviewing that year and an update on the recent literature. The committee will issue an annual letter report that addresses the following questions relevant to each evidence report: 1. Does the evidence report provide sufficient evidence, as well as sufficient risk context, that the risk is of concern for long-term space missions? 2. Does the evidence report make the case for the research gaps presented? 3. Are there any additional gaps in knowledge or areas of fundamental research that should be considered to enhance the basic understanding of this specific risk? 4. Does the evidence report address relevant interactions among risks? 5. Is input from additional disciplines needed? 6. Is the breadth of the cited literature sufficient? 7. What is the overall readability and quality? 8. Is the expertise of the authors sufficient to fully cover the scope of the given risk? 9. Has the evidence report addressed previous recommendations made by the IOM in the 2008 letter report?

Scott-Conner, Carol E. H.↗