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All sourcesNASA NTRSDOE OSTI
NASA NTRS1999

Publication Bias ( The "File-Drawer Problem") in Scientific Inference

Publication bias arises whenever the probability that a study is published depends on the statistical significance of its results. This bias, often called the file-drawer effect since the unpublished results are imagined to be tucked away in researchers' file cabinets, is potentially a severe impediment to combining the statistical results of studies collected from the literature. With almost any reasonable quantitative model for publication bias, only a small number of studies lost in the file-drawer will produce a significant bias. This result contradicts the well known Fail Safe File Drawer (FSFD) method for setting limits on the potential harm of publication bias, widely used in social, medical and psychic research. This method incorrectly treats the file drawer as unbiased, and almost always miss-estimates the seriousness of publication bias. A large body of not only psychic research, but medical and social science studies, has mistakenly relied on this method to validate claimed discoveries. Statistical combination can be trusted only if it is known with certainty that all studies that have been carried out are included. Such certainty is virtually impossible to achieve in literature surveys.

Scargle, Jeffrey D.↗
NASA NTRS2011

DoD-GEIS Rift Valley Fever Monitoring and Prediction System as a Tool for Defense and US Diplomacy

Over the last 10 years the Armed Forces Health Surveillance Center's Global Emerging Infections Surveillance and Response System (GEIS) partnering with NASA'S Goddard Space Flight Center and USDA's USDA-Center for Medical, Agricultural & Veterinary Entomology established and have operated the Rift Valley fever Monitoring and Prediction System to monitor, predict and assess the risk of Rift Valley fever outbreaks and other vector-borne diseases over Africa and the Middle East. This system is built on legacy DoD basic research conducted by Walter Reed Army Institute of Research overseas laboratory (US Army Medical Research Unit-Kenya) and the operational satellite environmental monitoring by NASA GSFC. Over the last 10 years of operation the system has predicted outbreaks of Rift Valley fever in the Horn of Africa, Sudan, South Africa and Mauritania. The ability to predict an outbreak several months before it occurs provides early warning to protect deployed forces, enhance public health in concerned countries and is a valuable tool use.d by the State Department in US Diplomacy. At the international level the system has been used by the Food and Agricultural Organization (FAD) and the World Health Organization (WHO) to support their monitoring, surveillance and response programs in the livestock sector and human health. This project is a successful testament of leveraging resources of different federal agencies to achieve objectives of force health protection, health and diplomacy.

Anyamba, Assaf↗
NASA NTRS2012

Virtual Guidance Ultrasound: A Tool to Obtain Diagnostic Ultrasound for Remote Environments

Astronauts currently acquire ultrasound images on the International Space Station with the assistance of real-time remote guidance from an ultrasound expert in Mission Control. Remote guidance will not be feasible when significant communication delays exist during exploration missions beyond low-Earth orbit. For example, there may be as much as a 20- minute delay in communications between the Earth and Mars. Virtual-guidance, a pre-recorded audio-visual tutorial viewed in real-time, is a viable modality for minimally trained scanners to obtain diagnostically-adequate images of clinically relevant anatomical structures in an autonomous manner. METHODS: Inexperienced ultrasound operators were recruited to perform carotid artery (n = 10) and ophthalmic (n = 9) ultrasound examinations using virtual guidance as their only instructional tool. In the carotid group, each each untrained operator acquired two-dimensional, pulsed, and color Doppler of the carotid artery. In the ophthalmic group, operators acquired representative images of the anterior chamber of the eye, retina, optic nerve, and nerve sheath. Ultrasound image quality was evaluated by independent imaging experts. RESULTS: Eight of the 10 carotid studies were judged to be diagnostically adequate. With one exception the quality of all the ophthalmic images were adequate to excellent. CONCLUSION: Diagnostically-adequate carotid and ophthalmic ultrasound examinations can be obtained by untrained operators with instruction only from an audio/video tutorial viewed in real time while scanning. This form of quick-response-guidance, can be developed for other ultrasound examinations, represents an opportunity to acquire important medical and scientific information for NASA flight surgeons and researchers when trained medical personnel are not present. Further, virtual guidance will allow untrained personnel to autonomously obtain important medical information in remote locations on Earth where communication is difficult or absent.

Caine,Timothy L.↗
NASA NTRS2023

A Pilot Project for Quantifying the Effect of Medical Provider Knowledge, Skills, and Abilities on Outcomes for Spaceflight Using a Probabilistic Risk Assessment Tool

In order to enable the future of long-duration deep space exploration we must confront the uncertainty in medical risk. Limitations of communication, resupply, and evacuation in deep space will require a high degree of crew autonomy and accurate risk assessment will be critical to ensure adequate crew training and medical system design. To address this, NASA’s Human Research Program Exploration Medical Capability Element has developed the Informing Mission Planning via Analysis of Complex Tradespaces Tool (IMPACT). IMPACT is a suite of tools that can provide evidence-based, data-driven trade space assessments between available medical resources in the mass- and volume-constrained environment of a deep space exploration vehicle. In the current model, medical conditions either can or cannot be treated based on the availability of medical system resources and equipment. However, medical outcomes often depend just as much on the knowledge, skills, and abilities (KSA) of the provider operating the system. This paper presents a method for modeling and quantifying the effect of medical officer KSA on medically relevant mission risk outcomes during spaceflight.

capabilities↗
NASA NTRS1999

NASA Johnson Space Center Biomedical Research Resources

Johnson Space Center (JSC) medical sciences laboratories constitute a national resource for support of medical operations and life sciences research enabling a human presence in space. They play a critical role in evaluating, defining, and mitigation the untoward effect of human adaption to space flight. Over the years they have developed the unique facilities and expertise required to perform: biomedical sample analysis and physiological performance tests supporting medical evaluations of space flight crew members and scientific investigations of the operationally relevant medical, physiological, cellular, and biochemical issues associated with human space flight. A general overview of these laboratories is presented in viewgraph form.

Paloski, W. H.↗
NASA NTRS2023

Identifying and Closing Medical Capability Gaps for Human Spaceflight Missions Beyond Low Earth Orbit

BACKGROUND: Features of human space missions beyond low Earth orbit such as increasing distance from Earth, lack of real-time communication, and limited or no evacuation or resupply capability are expected to drive an increase in medical risk and require crews to operate in an increasingly autonomous fashion. A diverse set of stakeholders at NASA are seeking to fund the development of concepts of operations, medical requirements, and medical capabilities for such missions. However, a systematic approach to identification of current medical capability gaps and a strategic framework to gap closure is needed. OVERVIEW: The Exploration Medical Integrated Product Team (XMIPT) has developed a list of nine high-level medical capability gaps and associated activities required for gap closure. The list was derived based on inputs from subject matter experts at NASA including flight surgeons, other clinical providers, as well as operational and research communities regarding medical capabilities required to support human missions to the Moon and the Mars surface. Responses were reviewed and distilled to identify common themes across capabilities. To ensure alignment with established human system risks, the gap list was further refined based on inputs from NASA’s Human System Risk Board. Relevant medical gap closure activities outside of those funded by the XMIPT were identified through solicitation of inputs from Elements of NASA’s Human Research Program (particularly Exploration Medical Capability), the broader medical operations community, and other stakeholders. This medical capability gap list is reviewed and updated regularly as new information becomes available or new stakeholders are identified. DISCUSSION: The medical capability gap list has matured to include a large group of NASA stakeholders and development activities. This has enabled articulation of priorities to funding entities and programmatic stakeholders, while serving as an accessible resource summarizing gap closure activities, relevant programmatic infusion points, and opportunities for collaboration between stakeholders. This presentation will provide an overview of the nine NASA medical capability gaps and their associated gap closure activities.

Moriah Thompson↗
NASA NTRSDate not supplied

Custom Integration of Multiple Medical Functionalities

INTRODUCTION: Previous spaceflight experience and results from probabilistic risk assessment of spaceflight medical risk have highlighted the need for vital sign measurements, medical scopes, and clinical imaging tools for managing medical conditions during spaceflight. The Human Research Program’s Exploration Medical Capability (ExMC) Element and the Mars Campaign Office’s Exploration Medical Integrated Product Team (XMIPT) have performed ground-based evaluations of two Commercial-off-the-Shelf (COTS) Multi-functional Integrated Medical (MIM) devices, which integrate various medical capabilities together in one device. The key findings from these evaluations are presented in a complementary presentation, leaving this presentation to focus on forward recommendations for customized integration of multiple medical functionalities. KEY COMPONENTS: The key features of a custom integration of multiple medical functionalities includes devices and capabilities that optimally reduce medical risk. The COTS MIM devices incorporated functionality for best supporting Earth-based, emergency, pre-hospital care. Our custom integration will use probabilistic risk assessment tools, such as the Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT), to determine the optimal functionality to include based on medical risk minimization. An additional feature of custom integration includes the ability to adapt to different requirements within different vehicles and/or missions. The COTS MIM devices store data in patient specific records, however, the format of the records is not modifiable, and data are not easily transferred from the MIM device to a central data architecture outside of the manufacturer’s established system. Our concept for custom integration will use devices that have an open application programming interface, which can easily connect to independent data architectures and third-party visualization software. The ultrasound capabilities included within the COTS MIM devices did not satisfy many of the Artemis Research and Operations Working Group’s ultrasound functional needs, and therefore, incorporation of higher quality ultrasound capabilities within a customized integration will be beneficial. The COTS MIM devices included minimal procedural guidance and clinical decision support tools. Supplemental tools of this type would need to be supplied along with the COTS MIM devices if they were to be used operationally, so another advantage of customization is the ability to integrate these support tools along with the medical functionality, for a more streamlined user experience. CONCLUSION: Investigation of a customized integration of medical functionality provides a method for further understanding the needs of a long-term exploration spaceflight medical system. The crew members of these exploration missions will need to operate more and more independently from Earth-based ground support. Therefore, having an optimized, streamlined medical system, which contains the functionality and supporting information needed, while remaining within mission and vehicle constraints, will help to maintain crew health and performance, which is necessary for achieving high levels of mission success.

B E Lewandowski↗
NASA NTRS1991

Use of telescience for biomedical research during space flight

When the U.S. first embarked on a manned space flight program, NASA's use of medical telescience was focused on crew health monitoring. In recent years, medical telescience use has been expanded to include support of basic research in space medicine. It enables ground support personnel to assist on-board crews in the performance of experiments and improves the quality and quantity of data return. NASA is continuing to develop its telescience capabilities. Future plans include telemedicine that will enable physicians on Earth to support crewmembers during flight and telescience that will enable investigators at their home institutions to support and conduct in-flight medical research. NASA's use of telescience for crew safety and biomedical research from Project Mercury to the present is described and NASA's plans for the future are presented.

Huntoon, Carolyn L.↗
NASA NTRS1982

Medical operations and life sciences activities on space station

Space station health maintenance facilities, habitability, personnel, and research in the medical sciences and in biology are discussed. It is assumed that the space station structure will consist of several modules, each being consistent with Orbiter payload bay limits in size, weight, and center of gravity.

Johnson, P. C.↗
NASA NTRS2017

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.↗
NASA NTRS2017

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↗
NASA NTRS2023

Machine Intelligence for Radiation Science: Summary of the Radiation Research Society 67th Annual Meeting Symposium

The era of high-throughput techniques created big data in the medical field and research disciplines. Machine intelligence (MI) approaches can overcome critical limitations on how those large-scale data sets are processed, analyzed, and interpreted. The 67 th Annual Meeting of the Radiation Research Society featured a symposium on MI approaches to highlight recent advancements in the radiation sciences and their clinical applications. This article summarizes three of those presentations regarding recent developments for metadata processing and ontological formalization, data mining for radiation outcomes in pediatric oncology, and imaging in lung cancer.

radiation↗
NASA NTRS2016

NASA Human System Risk Assessment Process

NASA utilizes an evidence based system to perform risk assessments for the human system for spaceflight missions. The center of this process is the multi-disciplinary Human System Risk Board (HSRB). The HSRB is chartered from the Chief Health and Medical Officer (OCHMO) at NASA Headquarters. The HSRB reviews all human system risks via an established comprehensive risk and configuration management plan based on a project management approach. The HSRB facilitates the integration of human research (terrestrial and spaceflight), medical operations, occupational surveillance, systems engineering and many other disciplines in a comprehensive review of human system risks. The HSRB considers all factors that influence human risk. These factors include pre-mission considerations such as screening criteria, training, age, sex, and physiological condition. In mission factors such as available countermeasures, mission duration and location and post mission factors such as time to return to baseline (reconditioning), post mission health screening, and available treatments. All of the factors influence the total risk assessment for each human risk. The HSRB performed a comprehensive review of all potential inflight medical conditions and events and over the course of several reviews consolidated the number of human system risks to 30, where the greatest emphasis is placed for investing program dollars for risk mitigation. The HSRB considers all available evidence from human research and, medical operations and occupational surveillance in assessing the risks for appropriate mitigation and future work. All applicable DRMs (low earth orbit for 6 and 12 months, deep space for 30 days and 1 year, a lunar mission for 1 year, and a planetary mission for 3 years) are considered as human system risks are modified by the hazards associated with space flight such as microgravity, exposure to radiation, distance from the earth, isolation and a closed environment. Each risk has a summary two-page assessment representing the state of knowledge/evidence of that risk, available risk mitigations, traceability to the Space Flight Human System Standards (SFHSS) and program requirements, and future work required. These data then can drive coordinated budgets across the Human Research Program, the International Space Station, Crew Health and Safety and Advanced Exploration System budgets to provide the most economical and timely mitigations. The risk assessments were completed for the 6 DRMs and serve as the baseline for which subsequent research and technology development and crew health care portfolios can be assessed. The HSRB reviews each risk at least annually or when new evidence/information is available that adds to the body of evidence. The current status of each risk can be reported to program management for operations, budget reviews and general oversight of the human system risk management program.

Francisco, D.↗
NASA NTRS2013

Future Challenges in Managing Human Health and Performance Risks for Space Flight

The global economy forces many nations to consider their national investments and make difficult decisions regarding their investment in future exploration. To enable safe, reliable, and productive human space exploration, we must pool global resources to understand and mitigate human health & performance risks prior to embarking on human exploration of deep space destinations. Consensus on the largest risks to humans during exploration is required to develop an integrated approach to mitigating risks. International collaboration in human space flight research will focus research on characterizing the effects of spaceflight on humans and the development of countermeasures or systems. Sharing existing data internationally will facilitate high quality research and sufficient power to make sound recommendations. Efficient utilization of ISS and unique ground-based analog facilities allows greater progress. Finally, a means to share results of human research in time to influence decisions for follow-on research, system design, new countermeasures and medical practices should be developed. Although formidable barriers to overcome, International working groups are working to define the risks, establish international research opportunities, share data among partners, share flight hardware and unique analog facilities, and establish forums for timely exchange of results. Representatives from the ISS partnership research and medical communities developed a list of the top ten human health & performance risks and their impact on exploration missions. They also drafted a multilateral data sharing plan to establish guidelines and principles for sharing human spaceflight data. Other working groups are also developing methods to promote international research solicitations. Collaborative use of analog facilities and shared development of space flight research and medical hardware continues. Establishing a forum for exchange of results between researchers, aerospace physicians and program managers takes careful consideration of researcher concerns and decision maker needs. Active participation by researchers in the development of this forum is essential, and the benefit can be tremendous. The ability to rapidly respond to research results without compromising publication rights and intellectual property will facilitate timely reduction in human health and performance risks in support of international exploration missions.

Corbin, Barbara J.↗
NASA NTRS2000

A national survey of policies on disclosure of conflicts of interest in biomedical research

BACKGROUND: Conflicts of interest pose a threat to the integrity of scientific research. The current regulations of the U.S. Public Health Service and the National Science Foundation require that medical schools and other research institutions report the existence of conflicts of interest to the funding agency but allow the institutions to manage conflicts internally. The regulations do not specify how to do so. METHODS: We surveyed all medical schools (127) and other research institutions (170) that received more than $5 million in total grants annually from the National Institutes of Health or the National Science Foundation; 48 journals in basic science and clinical medicine; and 17 federal agencies in order to analyze their policies on conflicts of interest. RESULTS: Of the 297 institutions, 250 (84 percent) responded by March 2000, as did 47 of the 48 journals and 16 of the 17 federal agencies. Fifteen of the 250 institutions (6 percent)--5 medical schools and 10 other research institutions--reported that they had no policy on conflicts of interest. Among the institutions that had policies, there was marked variation in the definition and management of conflicts. Ninety-one percent had policies that adhered to the federal threshold for disclosure ($10,000 in annual income or equity in a relevant company or 5 percent ownership), and 9 percent had policies that exceeded the federal guidelines. Only 8 percent had policies requiring disclosure to funding agencies, only 7 percent had such policies regarding journals, and only 1 percent had policies requiring the disclosure of information to the relevant institutional review boards or to research subjects. Twenty journals (43 percent) reported that they had policies requiring disclosure of conflicts of interest. Only four federal agencies had policies that explicitly addressed conflicts of interest in extramural research, and all but one of the agencies relied primarily on institutional discretion. CONCLUSIONS: There is substantial variation among policies on conflicts of interest at medical schools and other research institutions. This variation, combined with the fact that many scientific journals and funding agencies do not require disclosure of conflicts of interest, suggests that the current standards may not be adequate to maintain a high level of scientific integrity.

Human↗
NASA NTRS1992

Commercial opportunities in bioseparations and physiological testing aboard Space Station Freedom

The Center for Cell Research (CCR) is a NASA Center for the Commercial Development of Space which has as its main goal encouraging industry-driven biomedical/biotechnology space projects. Space Station Freedom (SSF) will provide long duration, crew-tended microgravity environments which will enhance the opportunities for commercial biomedical/biotechnology projects in bioseparations and physiological testing. The CCR bioseparations program, known as USCEPS (for United States Commercial Electrophoresis Program in Space), is developing access for American industry to continuous-flow electrophoresis aboard SSF. In space, considerable scale-up of continuous free-flow electrophoresis is possible for cells, sub cellular particles, proteins, growth factors, and other biological products. The lack of sedemination and buoyancy-driven convection flow enhances purity of separations and the amount of material processed/time. Through the CCR's physiological testing program, commercial organizations will have access aboard SSF to physiological systems experiments (PSE's); the Penn State Biomodule; and telemicroscopy. Physiological systems experiments involve the use of live animals for pharmaceutical product testing and discovery research. The Penn State Biomodule is a computer-controlled mini lab useful for projects involving live cells or tissues and macro molecular assembly studies, including protein crystallization. Telemicroscopy will enable staff on Earth to manipulate and monitor microscopic specimens on SSF for product development and discovery research or for medical diagnosis of astronaut health problems. Space-based product processing, testing, development, and discovery research using USCEPS and CCR's physiological testing program offer new routes to improved health on Earth. Direct crew involvement-in biomedical/biotechnology projects aboard SSF will enable better experimental outcomes. The current data base shows that there is reason for considerable optimism regarding what the CCDS program and the biomedical/biotechnology industry can expect to gain from a permanent manned presence in space.

Hymer, W. C.↗
NASA NTRSDate not supplied

Medical System Requirements Development for Lunar Operations

The major health hazards of spaceflight include higher levels of damaging radiation, altered gravity, extended periods of isolation and confinement, a closed and potentially hostile living environment, and the stress associated with being a long distance from Earth. As we increase the duration of lunar stays with foreseeable communication latencies and disruptions, there will be a progressive need for crew to maintain their own health and independently respond to critical medical events. The Exploration Medical Capability element of the NASA Human Research Program is developing a set of Medical System requirements for lunar transit and surface operations. These requirements specify the capabilities, processes and procedures of a habitat Medical System needed for a range of conditions known to occur during spaceflight. Requirement text is written so as not to constrain innovative design solutions necessary for a resilient system. The requirement set includes attributes and functions the Medical System imposes on eight additional habitat systems. A key property of the Medical System is the provision of medical knowledge that will be stored, updated, analyzed, and secured within a Habitat Data System. A Task Performance Support System will aid in medical data acquisition and interpretation, crew training, medical condition prevention, diagnosis and treatment, provide interactive procedures, and track medical inventory. A Wellness System will focus on the provision of countermeasures to prevent, mitigate or treat adverse physical and behavioral health effects while the Medical System recommends adjustments to these countermeasures to maintain crew health. An Environmental Monitoring System will share out-of-bounds readings of air and water quality, acoustics, and radiation exposure levels with the Medical System to help identify issues before they affect crew health and performance. A Communications System will provide secured and private consultations between crew and the ground medical team and their loved ones on Earth. The Medical System also imposes requirements on a Research & Testbed System, fostering advanced medical science such as human research. A Waste Management System provides biohazard waste containment and waste disposal options (recycle and reuse). An Extravehicular Activity System supports crew health during lunar surface activities. And finally, a Maintenance Support System ensures that medical equipment is performing as expected. These requirements are being specifically developed for lunar surface operations but could help to identify Medical System requirements for any space habitat (e.g., I-Hab, commercial endeavors, etc.).

technology↗