Review of NASA's Human Research Program Evidence Books A Letter Report (2008) / Chapter Skim
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Letter Report
Letter Report
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The body of this letter report provides the committee's findings and recommendations regarding NASA's compilation of the available evidence into reviews, or evidence books, as well as NASA's risk identification and assessment process. Overall, the committee believes NASA has developed a thorough and well-conceived framework for documenting the evidence base, establishing research priorities, and integrating research findings into occupational health and safety measures for the space crew.
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. CHARGE TO THE COMMITTEE In response to a request from the NASA Human Research Program, the IOM established an ad hoc committee to review each evidence book and assess the relevance of the identified human health-related risks for long-term spaceflight; appraise and clarify the descriptions of the risks; and assess the associated gaps in knowledge and identify additional areas for research (Box 1)
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In addition, NASA staff provided the first four evidence books for initial discussion. At the second meeting, the committee reviewed and assessed each evidence book, specifically evaluating each based on the following criteria: • Does the evidence book provide sufficient evidence that the risk is relevant to long-term space missions?
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Among the recommendations relevant to this study were incorporating quality-of-evidence measures for risks; representing risk severity separately from the state of the mitigation strategy or countermeasure; using standard uncertainty analysis techniques to quantify risk uncertainty; and ensuring that the Roadmap is viewed as a dynamic and current database rather than simply a static document. In addition, in 2007 the IOM released a letter report, Review of NASA's Space Flight Health Standards-Setting Process: Letter Report, that provided NASA with a set of recommendations on how it establishes space flight health standards for human performance (IOM, 2007)
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FINDINGS REGARDING SPECIFIC EVIDENCE BOOKS The committee commends NASA for taking the initial steps of assembling the documentation of scientific knowledge regarding the risks that have highest relevance to human health during long-duration spaceflight beyond low Earth orbit. These evidence books are part of a broader process to prioritize risks and associated research needs and to identify mitigation strategies.
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The Board also reviews the potential risks for relevance to the mission, in cluding, among other things, operational mission impact, acute and long-term health risks, and performance impacts. the need to improve the relevancy of the identified risks and discussion of additional knowledge gaps and potential associations between related risks -- overall the committee believes that they are valuable resources and important components to the overall process, reflecting the current state of knowledge on health risks associated with spaceflight, and believes if the evidence books are kept current, their value will increase over time.
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Further, the committee makes a number of suggestions to address instances in the set of evidence books where there was unevenness, lack of clarity in the scope of the review, readability issues, or other issues such as lack of definition of physiological requirements and benchmarks. Modifying the Scope and Focus of the Evidence Books The committee found the identified health risks to be largely relevant as potential threats to long-term space missions.
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Cardiovascular Effects on Performance and Operational Limitations The committee found that the topic of evidence book #10, Cardiovascular Effects on Performance and Operational Limitations, is a subset of the broader issue of the effects of decrements in work capacity on operational performance. In some cases that involve sustained higher level energy expenditure (e.g., "the lunar 10K walk back" scenario)
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Behavioral and psychiatric problems have been viewed as operational medical issues that are held confidential, rather than as a health-related research agenda that deserves co-equal status with somatic health issues. The committee believes the potential seriousness of the psychological and behavioral health risks highlights the need for the evidence book to contain a review and any relevant data, including an analysis of newer instruments and scales for evaluating more subtle personality differences.
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issues focused on strengthening the content and format of the evidence books, and (2) issues relevant to improving the process of updating and disseminating the evidence on human health risks.
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; • Include, or link to, a summary of the current state of knowledge regarding countermea sures and the plan to mitigate risk; • Improve the consistency and organization of the discussions on identified research gaps; • Increase the emphasis on potential postflight and long-term health outcomes; and • Develop evidence books on additional risks, including alterations in microbe and host in teractions and impaired healing function. Expand the Literature Base and Categorize the Quality of Evidence The authors of the evidence books were asked to include the risk statements as they were written in the PRD, and review the risks based on published and unpublished scientific and clinical evidence from data collected from space- and ground-based research on humans, animals, and other models.
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In NASA's instructions the authors of the evidence books were encouraged, but not required, to label evidence using its four categories.1 However, to clarify the type of evidence presented and to provide additional information regarding the strength of evidence, the committee believes NASA should require authors to use categories of evidence in future versions of the evidence books, while recognizing that experience with the explicit categorization of evidence may be refined over time, particularly regarding the categories used. Apart from the absence of quality-of-evidence criteria, the first evidence book, Impaired Ability to Maintain Control of Vehicles and Other Complex Systems, stands out as a model for the clear presentation of a risk, the relevant evidence, and associated research gaps.
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Summarize the State of the Knowledge on Countermeasures Each evidence book included the primary knowledge gaps associated with each risk, as identified by the authors. Although the authors were instructed not to address potential mitigation strategies or known mitigation gaps, the committee believes that countermeasures are an important component of the evidence books and are integral to understanding the current state of scientific knowledge and the severity of the potential impact of the risks on the individual and the mission.
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Since one of the major goals of the evidence books is to provide the evidence base on which to improve human health and reduce health risks associated with spaceflight, it is important to organize the discussion of research gaps so that their operational impact will be evident and the type of research or other actions needed to move forward is clearly defined. Therefore, the committee encourages NASA to develop a more uniform approach to how the gaps associated with each risk are presented.
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The implications of poor wound healing, combined with the statistical prediction of the likelihood of traumatic injury contained in the evidence book on the risk of inadequate medical care, make a compelling case for an expanded research program in this area. Continue to Improve NASA's Process for Updating and Disseminat ing the Evidence on Human Health Risks The committee believes NASA has developed a thorough and wellconceived framework for documenting the evidence base, establishing research priorities, and integrating research findings into occupational health and safety measures for the space crew.
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Reviewing and Updating the Evidence Books The committee encourages NASA to broaden the responsibility of the risk forums and Human System Risk Board by integrating into these mechanisms a formal and documented strategy for periodically reviewing and updating the evidence books. NASA plans annual reviews of the current set of evidence books; however, the process for these reviews is still in development.
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Basic comparative information regarding probabilities and severities of risks relative to one another may contribute to understanding, interpreting, and communicating the practical risk management implications of the research summarized in the evidence books.
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NASA may wish to take advantage of newer methods of community-based editing, such as the Wikipedia model, by inviting appropriately credentialed and authorized experts in the areas covered by the risk evidence books to interactively update the current best evidence online. Because opportunities for data collection on human response to microgravity and other relatively unique aspects of space exploration are so limited, NASA needs to fully employ the available methods and venues to collect and analyze astronaut health data.
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