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Under the Artemis lunar exploration program, NASA is committed to landing American astronauts on the moon by 2024. While NASA’s new Space Launch System rocket and Orion capsule will carry astronauts from Earth to the Gateway, the human lunar landing system has not yet been fully defined. As in the Apollo program, there are concerns for vehicle weight and internal volume such that seats may not be desirable, and standing during lunar descent and ascent may be a preferred engineering solution. With such a design, astronauts will experience +GZ (head-to-foot) accelerations during capsule accelerations, and it is unclear whether spaceflight deconditioned astronauts can tolerate these. Apollo astronauts stood during lunar descent and ascent, and the data contained in the early program records for those missions represent a unique resource that may provide insights to the cardiovascular stress associated with this human landing system design.

Vision changes identified in long duration spaceflight astronauts has led Space Medicine at NASA to adopt a more comprehensive clinical monitoring protocol. Optical Coherence Tomography (OCT) was recently implemented at NASA, including on board the International Space Station in 2013. NASA is collaborating with Heidelberg Engineering to increase the fidelity of the current OCT data set by integrating the traditional circumpapillary OCT image with radial and horizontal block images at the optic nerve head. The retinal nerve fiber layer was segmented by two experienced individuals. Intra-rater (N=4 subjects and 70 images) and inter-rater (N=4 subjects and 221 images) agreement was performed. The results of this analysis and the potential benefits will be presented.

Retrospective research and medical data collected on astronauts can be a valuable resource for researchers. This data can be requested from two separate NASA Archives. The Lifetime Surveillance of Astronaut Health (LSAH) holds astronaut medical data, and the Life Sciences Data Archive (LSDA) holds research data. One condition of use of astronaut research and medical data is the requirement that all abstracts, publications and presentations using this data must be reviewed for attributability. All final versions of abstracts, presentations, posters, and manuscripts must be reviewed by LSDA/LSAH prior to submission to a conference, journal, or other entities outside the Principal Investigator (PI) laboratory [including the NASA Export Control Document Availability Authorization (DAA) system]. If material undergoes multiple revisions (e.g., journal editor comments), the new versions must also be reviewed by LSDA/LSAH prior to re-submission to the journal. The purpose of this review is to ensure that no personally identifiable information (PII) is included in materials that are presented in a public venue or posted to the public domain. The procedures for submitting materials for review will be outlined. The process that LSAH/LSDA follows for assessing attributability will be presented. Characteristics and parameter combinations that often prompt attributability concerns will be identified. A published case report for a National Football League (NFL) player will be used to demonstrate how, in a population of public interest, a combination of information can result in inadvertent release of private or sensitive information.

The Heidelberg Spectralis "OCT2", which recently became commercially available, is going to be implemented at the Johnson Space Center Flight Medicine Clinic and on board the International Space Station. Due to the increased scan rate of the "OCT2", this upgrade will allow for significant reduction in valuable crew testing time and also allow for additional capabilities, like OCT Angiography and Multi-Color Fundus Imaging. Due to the custom scans used to monitor Space Flight-Associated Neuro-ocular Syndrome (SANS) in our crewmembers, an evaluation to assess the impacts of transitioning from "OCT1" to "OCT2" was performed. An engineering assessment (N=1) was performed to identify any potential impacts of maintaining an "OCT1" on board ISS while implementing an "OCT2" in the JSC Clinic. "OCT2" implementation will lag JSC FMC clinical implementation due to the flight certification/manifestation process. The clinical assessment was performed (n=12) to identify any impacts due to the replacement of the "OCT1" with the "OCT2" to the longitudinal OCT data across a crewmember's mission/lifetime. The qualitative results from the engineering and clinical evaluation will be reported, as well as the quantitative assessment of the clinical variables

Enhanced screening for the Visual Impairment/Intracranial Pressure (VIIP) syndrome has been implemented to better characterize the ocular and vision changes observed in some long-duration crewmembers. This includes implementation of in-flight ultrasound in 2010 and optical coherence tomography (OCT) in 2013. Potential risk factors for VIIP include cardiovascular health, diet, anatomical and genetic factors, and environmental conditions. Carbon dioxide (CO2), a potent vasodilator, is chronically elevated on the International Space Station (ISS) relative to ambient levels on Earth, and is a plausible risk factor for VIIP. In an effort to understand the possible associations between CO2 and VIIP, this study explores the relationship of ambient CO2 levels on ISS compared to inflight ultrasound and OCT measures of the eye obtained from ISS crewmembers. CO2 measurements were aggregated from Operational Data Reduction Complex and Node 3 major constituent analyzers (MCAs) on ISS or from sensors located in the European Columbus module, as available. CO2 levels in the periods between each ultrasound and OCT session are summarized using timeseries metrics, including time-weighted means and variances. Partial least squares regression analyses are used to quantify the complex relationship between specific ultrasound and OCT measures and the CO2 metrics simulataneously. These analyses will enhance our understanding of the possible associations between CO2 levels and structural changes to the eye which will in turn inform future analysis of inflight VIIP data.

Since the 2010 NASA directive to make the Life Sciences Data Archive (LSDA) and Lifetime Surveillance of Astronaut Health (LSAH) data archives more accessible by the research and operational communities, demand for astronaut medical data has increased greatly. LSAH and LSDA personnel are working with Human Research Program on many fronts to improve data access and decrease lead time for release of data. Some examples include the following: Feasibility reviews for NASA Research Announcement (NRA) data mining proposals; Improved communication, support for researchers, and process improvements for retrospective Institutional Review Board (IRB) protocols; Supplemental data sharing for flight investigators versus purely retrospective studies; Work with the Multilateral Human Research Panel for Exploration (MHRPE) to develop acceptable data sharing and crew consent processes and to organize inter-agency data coordinators to facilitate requests for international crewmember data. Current metrics on data requests crew consenting will be presented, along with limitations on contacting crew to obtain consent. Categories of medical monitoring data available for request will be presented as well as flow diagrams detailing data request processing and approval steps.

BACKGROUND: Historically, colonoscopy screenings for astronauts have been conducted to ensure that astronauts are in good health for space missions. Recently this historical data has been identified as being useful for developing an occupational surveillance requirement. It can be used to assess overall colon health and to have a point of reference for future tests in current and former astronauts, as well as to follow-up and track rates of colorectal cancer and polyps. These rates can be compared to military and other terrestrial populations. In 2003, the active astronaut colonoscopy requirements changed to require less frequent colonoscopies. Since polyp removal during a colonoscopy is an intervention that prevents the polyp from potentially developing into cancer, the procedure decreases the individual's risk for colon cancer. The objective of this study is to evaluate the possible effect of increased follow-up times between colonoscopies on the number and severity of polyps identified during the procedures among both current and former NASA astronauts. Initial results and forward work regarding astronaut colonoscopy screenings will be presented. METHODS: A retrospective study of all colonoscopy procedures performed on NASA astronauts between 1962 and 2015 (both during active career and retirement) was conducted by review of the JSC Clinic Electronic Medical Record and Lifetime Surveillance of Astronaut Health (LSAH) database for colonoscopy screening procedures and pathology reports. The timeframe of interest was from the time of selection into the Astronaut Corps through May 2015 or death. For each colonoscopy report, the following data were captured: date of procedure, age at time of procedure, reason for procedure, quality of bowel prep, completion of procedure and/or reason for termination of procedure, findings of procedure, subsequent treatment (if any), recommended follow-up interval, actual follow up interval, family history of polyps or colon cancer, and other significant items or discrepancies. The population consisted of 338 astronauts: 52 females, 286 males. Of these, 56 were deceased, and 11 astronauts had no record of any colonoscopies. Because of a screening requirement change in 2003, analyses were conducted to determine if there were differences between the two time periods. One-sided Wilcoxon rank sum tests were used to identify statistically significant differences between the two time periods. RESULTS: There was a combined total of 1,964 colonoscopy screenings identified. The average follow-up intervals between colonoscopies were indeed longer after the screening requirement change than before the change. The mean follow-up interval pre -2003 was 3.59 years, while post-2003 it increased to 4.35 years. The statistical significance of this difference was confirmed using a one sided Wilcoxon rank sum test which yielded p<.001. Colonoscopies performed after the requirement change tended to have a higher incidence and greater severity of polyps. From pre-2003 to post-2003 the percentage of colonoscopy procedures yielding no polyps decreased from 83.77% to 74.70%. Not only did post-2003 procedures yield more polyp findings, but the polyps recorded were more often of severe pathology. Before 2003 3.62% of colonoscopy findings were polyps of the hyperplastic type (the least severe polyp type) and only 3.35% were of greater severity. Post-2003, 4.21% of findings were hyperplastic polyps while 11.44% were of greater severity. Upon the investigation of other possible contributing factors to these results, we also found that mean age post-2003 was 54.55 years which was significantly higher than during the pre-2003 timeframe (47.32 years). This was observed with a one-sided Wilcoxon rank sum test, resulting in a p<0.001. The increased average age of astronauts could also be a contributing factor to the greater number of polyps found since the risk of developing polyps increases with age. Further work is needed to better understand the increased incidence and greater severity of polyps found in astronaut colonoscopy outcomes.

Understanding the kinds of evidence available and using the best evidence to answer a question is critical to evidenced-based decision-making, and it requires synthesis of evidence from a variety of sources. Categorization of human system risks in spaceflight, in particular, focuses on how well the integration and interpretation of all available evidence informs the risk statement that describes the relationship between spaceflight hazards and an outcome of interest. A mature understanding and categorization of these risks requires: 1) sufficient characterization of risk, 2) sufficient knowledge to determine an acceptable level of risk (i.e., a standard), 3) development of mitigations to meet the acceptable level of risk, and 4) identification of factors affecting generalizability of the evidence to different design reference missions. In the medical research community, evidence is often ranked by increasing confidence in findings gleaned from observational and experimental research (e.g., "levels of evidence"). However, an approach based solely on aspects of experimental design is problematic in assessing human system risks for spaceflight. For spaceflight, the unique challenges and opportunities include: (1) The independent variables in most evidence are the hazards of spaceflight, such as space radiation or low gravity, which cannot be entirely duplicated in terrestrial (Earth-based) analogs, (2) Evidence is drawn from multiple sources including medical and mission operations, Lifetime Surveillance of Astronaut Health (LSAH), spaceflight research (LSDA), and relevant environmental & terrestrial databases, (3) Risk metrics based primarily on LSAH data are typically derived from available prevalence or incidence data, which may limit rigorous interpretation, (4) The timeframe for obtaining adequate spaceflight sample size (n) is very long, given the small population, (5) Randomized controlled trials are unattainable in spaceflight, (6) Collection of personal and environmental data on the astronaut population may create opportunities for advanced analytics and human-environment modeling that goes beyond that achieved in isolated experimental designs; and (7) Translation of relevant research to operations is a complex, transdisciplinary enterprise in which the approach must apply across the physical, biological, behavioral, and social sciences. The approach to synthesizing evidence must address both source and fidelity of data, and reflect the most general attributes of quality of evidence in science and engineering: reliability and validity. The authors are developing a two-factor approach which includes the various kinds of evidence required to understand risks and for the integrated interpretation of all evidence that is essential to develop standards and countermeasures. A unified framework for aggregating and assessing different kinds of evidence provides a consistent, traceable, evidence-based decision-making process to translate research to operations in an environment where engineers, scientists, physicians, and managers all engage in analyzing the trade space of vehicle design, standards, requirements and solutions for spaceflight.

Training for a spacewalk or extravehicular activity (EVA) is considered a hazardous duty for NASA astronauts. This places astronauts at risk for decompression sickness as well as various musculoskeletal disorders from working in the spacesuit. As a result, the operational and research communities over the years have requested access to EVA training data to supplement their studies. The purpose of this paper is to document the comprehensive EVA training data set that was compiled from multiple sources by the Lifetime Surveillance of Astronaut Health (LSAH) epidemiologists to investigate musculoskeletal injuries. The EVA training dataset does not contain any medical data, rather it only documents when EVA training was performed, by whom and other details about the session. The first activities practicing EVA maneuvers in water were performed at the Neutral Buoyancy Simulator (NBS) at the Marshall Spaceflight Center in Huntsville, Alabama. This facility opened in 1967 and was used for EVA training until the early Space Shuttle program days. Although several photographs show astronauts performing EVA training in the NBS, records detailing who performed the training and the frequency of training are unavailable. Paper training records were stored within the NBS after it was designated as a National Historic Landmark in 1985 and closed in 1997, but significant resources would be needed to identify and secure these records, and at this time LSAH has not pursued acquisition of these early training records. Training in the NBS decreased when the Johnson Space Center in Houston, Texas, opened the Weightless Environment Training Facility (WETF) in 1980. Early training records from the WETF consist of 11 hand-written dive logbooks compiled by individual workers that were digitized at the request of LSAH. The WETF was integral in the training for Space Shuttle EVAs until its closure in 1998. The Neutral Buoyancy Laboratory (NBL) at the Sonny Carter Training Facility near JSC opened in March 1997 and is the current site for US EVA training. Other space agencies also have used water to simulate weightlessness and train for EVAs. Russia has a training facility similar to the NBL named the Hydro Lab. The Hydro Lab began operations at the Gagarin Cosmonaut Training Center (GCTC) in 1980 and has been used extensively to the present. Although a majority of training in the Hydro Lab uses the Russian Orlan suit, a small number of sessions have been conducted using a NASA suit. The Japanese Weightlessness Environment Test System (WETS) went into service at the Tsukuba Space Center in 1997 but was closed in 2011 due to extensive earthquake damage. Several sessions were performed using a NASA suit, but these sessions were short and considered "development" runs. LSAH has assembled records from the WETF, NBL and Hydro Lab. Recording of the EVA training data has changed considerably from 1967 to present. The goal of early record keeping was to track use of hardware components, and the person involved was treated as a suited operator, not as a focus of interest. Records from the past two decades are fairly precise with the person, date, suit type and size noted. On occasion the length of the session was listed, but this data is not included on all records. Records were merged from data sources and extensive cleaning of the records was required since the multiple sources frequently overlapped and duplicated records. To date the LSAH EVA training dataset includes over 12,500 EVA training sessions performed by NASA astronauts since 1981. The following variables are included for most records: Name, Sex, Event date, Event name, HUT type, HUT size, Facility, and Estimated run time. For a smaller subset of records, the following variables are available: Actual run time, Time inverted, and the suit components Waist bearing type, Shoulder harness, Shoulder pads, and Teflon inserts. The LSAH dataset is currently the most complete resource for data regarding EVA training sessions performed by NASA astronauts. However, it is not 100 percent complete since the WETS (Japan) and NBS (Marshall) training facility data were not included. This dataset has been compiled by LSAH to study the relationship of EVA training to musculoskeletal injuries but has many other non-medical applications. This dataset can be provided to other groups in order to respond to program and research questions with appropriate board approvals.

Enhanced screening for the Visual Impairment/Intracranial Pressure (VIIP) Syndrome, including in-flight ultrasound, was implemented in 2010 to better characterize the changes in vision observed in some long-duration crewmembers. Suggested possible risk factors for VIIP include cardiovascular changes, diet, anatomical and genetic factors, and environmental conditions. As a potent vasodilator, carbon dioxide (CO (sub 2)), which is chronically elevated on the International Space Station (ISS) relative to typical indoor and outdoor ambient levels on Earth, seems a plausible contributor to VIIP. In an effort to understand the possible associations between CO (sub 2) and VIIP, this study analyzes the relationship between ambient CO (sub 2) levels on ISS and ultrasound measures of the eye obtained from ISS fliers. CO (sub 2) measurements will be pulled directly from Operational Data Reduction Complex for the Lab and Node 3 major constituent analyzers (MCAs) on ISS or from sensors located in the European Columbus module, as available. CO (sub 2) measures between ultrasound sessions will be summarized using standard time series class metrics in MATLAB including time-weighted means and variances. Cumulative CO (sub 2) exposure metrics will also be developed. Regression analyses will be used to quantify the relationships between the CO (sub 2) metrics and specific ultrasound measures. Generalized estimating equations will adjust for the repeated measures within individuals. Multiple imputation techniques will be used to adjust for any possible biases in missing data for either CO (sub 2) or ultrasound measures. These analyses will elucidate the possible relationship between CO (sub 2) and changes in vision and also inform future analysis of inflight VIIP data.

Occupational surveillance of astronaut shoulder injuries began with operational concerns at the Neutral Buoyancy Laboratory (NBL) during Extra Vehicular Activity (EVA) training. Orthopedic shoulder injury and surgery rates were calculated [1], but classifying the rates as normal, high or low was highly dependent on the comparison group. Thus, the purpose of this study was to identify a population of working professionals and compare orthopedic shoulder consultation and surgery rates.

Carbon dioxide (CO2) levels on ISS have typically averaged 2.3 to 5.3mm Hg, with large fluctuations occurring over periods of hours and days. CO2 has effects on cerebral vascular tone, resulting in vasodilation and alteration of cerebral blood flow(CBF). Increased CBF leads to elevated intracranial pressure(ICP), which is a factor leading to visual disturbance, headaches, and other central nervous system symptoms. Ultrasound of the optic nerve provides a surrogate measurement of ICP. Inflight ultrasounds were implemented as an enhanced screening tool for the Visual Impairment/Intracranial Pressure (VIIP) Syndrome. This analysis examines the relationships between ambient CO2 levels on ISS and ultrasound measures of the eye in an effort to understand how CO2 may be associated with VIIP and to inform future analysis of inflight VIIP data. Results as shown in Figure2, there was a large timeframe where CO2 readings were removed due to sensor fault errors(see Limitations), from June 2011 to January 2012. After extensive cleaning of the CO2 data, metrics for all of the data were calculated (Table2). Preliminary analyses showed possible associations between variability measures of CO2 and AP diameter (Figure3),and average CO2 exposure and ONSD(Figure4). Adjustments for multiple comparisons were not made due to the exploratory nature of the analysis.

INTRODUCTION Back pain during spaceflight has often been attributed to the lengthening of the spinal column due to the absence of gravity during both short and long-duration missions. Upon landing and re-adaptation to gravity, the spinal column reverts back to its original length thereby causing some individuals to experience pain and muscular spasms, while others experience no ill effects. With International Space Station (ISS) missions, cases of back pain and injury are more common post-flight, but little is known about the potential risk factors. Thus, the purpose of this project was to perform an initial evaluation of reported post-flight back pain and injury cases to relevant spaceflight risk factors in United States astronauts that have completed an ISS mission. METHODS All US astronauts who completed an ISS mission between Expeditions (EXP) 1 and 41 (2000-2015) were included in this evaluation. Forty-five astronauts (36 males and 9 females) completed 50 ISS missions during the study time period, as 5 astronauts completed 2 ISS missions. Researchers queried medical records of the 45 astronauts for occurrences of back pain and injury. A case was defined as any reported event of back pain or injury to the cervical, thoracic, lumbar, sacral, or coccyx spine regions. Data sources for the cases included the Flight Medicine Clinic's electronic medical record; Astronaut Strength, Conditioning and Rehabilitation electronic documentation; the Private Medical Conference tool; and the Space Medicine Operations Team records. Post-flight cases were classified as an early case if reported within 45 days of landing (R + 45) or a late case if reported from R + 46 to R + 365 days after landing (R + 1y). Risk factors in the astronaut population for back pain include age, sex, prior military service, and prior history of back pain. Additionally, spaceflight specific risk factors such as type of landing vehicle and onboard exercise countermeasures were included to evaluate their contribution to post-flight cases. Prior history of back pain included back pain recorded in the medical record within 3 years prior to launch. Landing vehicle was included in the model to discern if more astronauts experienced back pain or injury following a Shuttle or Soyuz landing. Onboard exercise countermeasures were noted for those astronauts who had a mission following 2009 deployment of the Advanced Resistive Exercise Device (aRED) (EXP 19 to 41). T-test and chi-squared tests were performed to evaluate the association between each individual risk factor and post-flight case. Logistic regression was used to evaluate the combined contribution of all the risk factors on post-flight cases. Separate models were calculated for cases reported by R + 45 and R + 1y. RESULTS During the study time period, there were 13 post-flight cases reported by R + 45 and an additional 5 reported by R + 1y. Most of these cases have been reported since EXP 19 with 10 cases by R + 45 and 4 by R + 1y. Individual risk factors of age, sex, landing vehicle, and prior military service were not significantly associated with post-flight cases identified at R + 45 or R + 1y (p greater than 0.05). Having back pain or injury within 3 years prior to launch significantly increased the likelihood of becoming a case by R + 1y (p = 0.041), but not at R+45 (p=0.204). Additionally, astronauts who experienced onboard exercise countermeasures that included aRED had a significantly increased risk of becoming a case at R + 45 (p = 0.024) and R + 1y (p=0.003). Multiple logistic regression evaluating all the risk factors for cases identified no significant risk factors at either the R + 45 or R + 1y time period (p greater than 0.05). Overall model fit was poor for both the R + 45 (R(exp 2) = 0.132) and R + 1y (R(exp 2) = 0.186) cases showing that there are risk factors not represented in our model. CONCLUSIONS Regardless of cause, post-flight cases are reported more often since aRED was deployed in 2009. This may reflect improved documentation or unidentified risk factors. No spaceflight risk factor explains the data fully. Post-flight cases are probably due to multi-faceted factors that are not easily elucidated in the medical data.

The One Year Mission (1YM) by two astronauts on the International Space Station (ISS), starting in March 2015, offers a unique opportunity to expand multilateral collaboration by sharing data and resources among the partner agencies in preparation for planned space exploration missions beyond low Earth orbit. Agreements and protocols will be established for the collection, distribution, analysis and reporting of both research and clinical data. Data will be shared between the agencies sponsoring the investigators, and between the research and clinical medicine communities where common interests are identified. The assignment of only two astronauts, one Russian and the other American, to the 1YM necessitated creativity in bilateral efforts to maximize the biomedical return from the opportunity. Addition of Canadian, European and Japanese investigations make the effort even more integrative. There will be three types of investigations: joint, cross‐participation and data‐exchange. The joint investigations have US and Russian coprincipal investigators, and the data acquired will be their common responsibility. The other two types must develop data sharing agreements and processes specific to their needs. A multilateral panel of ISS partner space agencies will develop policies for international exchange of scientific information to meet their science objectives and priorities. They will promote archiving of space flight data and will inform each other and the scientific community at large about the results obtained from space life sciences studies. Integration tasks for the 1YM are based on current experience from the ISS and previous efforts on the Russian space station Mir. Closer coordination between international partners requires more common approaches to remove barriers to multilateral resource utilization on the ISS. Greater integration in implementation should increase utilization efficiency to benefit all participants in spaceflight human research. This presentation will describe the overarching principles for multilateral data collection, analysis and sharing and for data security for medical and research data shared between ISS partners prior to release in public forums.

Understanding the nuances in clinical data is critical in developing a successful data analysis plan. Carbon dioxide (CO2) data are collected on board the International Space Station (ISS) in a continuous stream. Clinical data on ISS are primarily collected via conversations between individual crewmembers and NASA Flight Surgeons during weekly Private Medical Conferences (PMC). Law, et.al, 20141 demonstrated a statistically significant association between weekly average CO2 levels on ISS and self-reported headaches over the reporting period from March 14, 2001 to May 31, 2012. The purpose of this analysis is to describe the evaluation of a possible association between visual changes and CO2 levels on ISS and to discuss challenges in developing an appropriate analysis plan. METHODS & PRELIMINARY RESULTS: A first analysis was conducted following the same study design as the published work on CO2 and self-reported headaches1; substituting self-reported changes in visual acuity in place of self-reported headaches. The analysis demonstrated no statistically significant association between visual impairment characterized by vision symptoms self-reported during PMCs and ISS average CO2 levels over ISS missions. Closer review of the PMC records showed that vision outcomes are not well-documented in terms of clinical severity, timing of onset, or timing of resolution, perhaps due to the incipient nature of vision changes. Vision has been monitored in ISS crewmembers, pre- and post-flight, using standard optometry evaluations. In-flight visual assessments were limited early in the ISS program, primarily consisting of self-perceived changes reported by crewmembers. Recently, on-orbit capabilities have greatly improved. Vision data ranges from self-reported post-flight changes in visual acuity, pre- to postflight changes identified during fundoscopic examination, and in-flight progression measured by advanced on-orbit clinical imaging capabilities at predetermined testing intervals. In contrast, CO2 data are recorded in a continuous stream over time; however, for the initial analysis this data was categorized into weekly averages.

This viewgraph presentation reviews the radiation exposures and risks associated with long-term spaceflight on the International Space Station. NASA's risk model of cancer mortality is also presented.