ALBERT

Description: Management guidelines were created to screen and manage asymptomatic renal stones in U.S. astronauts. The true risk for renal stone formation in astronauts due to the space flight environment is unknown. Proper management of this condition is crucial to mitigate health and mission risks. The NASA Flight Medicine Clinic electronic medical record and the Lifetime Surveillance of Astronaut Health databases were reviewed. An extensive review of the literature and current aeromedical standards for the monitoring and management of renal stones was also done. This work was used to develop a screening and management protocol for renal stones in astronauts that is relevant to the spaceflight operational environment. In the proposed guidelines all astronauts receive a yearly screening and post-flight renal ultrasound using a novel ultrasound protocol. The ultrasound protocol uses a combination of factors, including: size, position, shadow, twinkle and dispersion properties to confirm the presence of a renal calcification. For mission-assigned astronauts, any positive ultrasound study is followed by a low-dose renal computed tomography scan and urologic consult. Other specific guidelines were also created. A small asymptomatic renal stone within the renal collecting system may become symptomatic at any time, and therefore affect launch and flight schedules, or cause incapacitation during a mission. Astronauts in need of definitive care can be evacuated from the International Space Station, but for deep space missions evacuation is impossible. The new screening and management algorithm has been implemented and the initial round of screening ultrasounds is under way. Data from these exams will better define the incidence of renal stones in U.S. astronauts, and will be used to inform risk mitigation for both short and long duration spaceflights.

Description: INTRODUCTION: Among otherwise healthy astronauts undertaking deep space missions, the risks for acute appendicitis (AA) and cholecystitis (AC) are not zero. If these conditions were to occur during spaceflight they may require surgery for definitive care. The proposed study quantifies and compares the risks of developing de novo AA and AC in-flight to the surgical risks of prophylactic laparoscopic appendectomy (LA) and cholecystectomy (LC) using NASA's Integrated Medical Model (IMM). METHODS: The IMM is a Monte Carlo simulation that forecasts medical events during spaceflight missions and estimates the impact of these medical events on crew health. In this study, four Design Reference Missions (DRMs) were created to assess the probability of an astronaut developing in-flight small-bowel obstruction (SBO) following prophylactic 1) LA, 2) LC, 3) LA and LC, or 4) neither surgery (SR# S-20160407-351). Model inputs were drawn from a large, population-based 2011 Swedish study that examined the incidence and risks of post-operative SBO over a 5-year follow-up period. The study group included 1,152 patients who underwent LA, and 16,371 who underwent LC. RESULTS: Preliminary results indicate that prophylactic LA may yield higher mission risks than the control DRM. Complete analyses are pending and will be subsequently available. DISCUSSION: The risk versus benefits of prophylactic surgery in astronauts to decrease the probability of acute surgical events during spaceflight has only been qualitatively examined in prior studies. Within the assumptions and limitations of the IMM, this work provides the first quantitative guidance that has previously been lacking to this important question for future deep space exploration missions.

Description: After an initial stone episode persons are at increased risk for future stone formation. A systematic approach is required to monitor the efficacy of treatment and preventive measures, and to assess the risk of developing new stones. This is important for persons working in critical jobs or austere environments, such as astronauts. A literature review of the current standards of care for renal stone monitoring and imaging was done. Military and civil aviation standards were also reviewed, as well as the medical precedents from the space program. Additionally, a new, more effective, renal stone ultrasound protocol has been developed. Using this work, a monitoring algorithm was proposed that takes into consideration the unique mission and operational environment of spaceflight. The approach to imaging persons with history of renal stones varies widely in the literature. Imaging is often done yearly or biannually, which may be too long for mission critical personnel. In the proposed algorithm astronauts with a history of renal stone, who may be under consideration for assignment, are imaged by a detailed, physiciandriven, ultrasound protocol. Unassigned personnel are monitored by yearly ultrasound and urine studies. Any positive ultrasound study is then followed by low-dose renal computed tomography scan. Other criteria are also established. The proposed algorithm provides a balanced approach between efficacy and reduced radiation exposure for the monitoring of astronauts with a renal stone history. This may eventually allow a transition from a risk-averse, to a risk-modifying approach that can enable continued service of individuals with history of renal stone that have adequately controlled risk factors.

Description: No abstract available

Description: Ultrasound (US) specifically looking for asymptomatic renal calcifications that may be renal stones is typically not done in the terrestrial setting. Standard abdominal US without a renal focus may discover incidental, mineralized renal material (MRM); however punctate solid areas of MRM is less than 3 mm are usually considered subclinical. Detecting these early calcifications before they become symptomatic renal stones is critical to prevent adverse medical and mission outcomes during spaceflight.

Description: Introduction: Management guidelines were created to screen and manage asymptomatic renal stones in U.S. astronauts. The risks for renal stone formation in astronauts due to bone loss and hypercalcuria are unknown. Astronauts have a stone risk which is about the same as commercial aviation pilots, which is about half that of the general population. However, proper management of this condition is still crucial to mitigate health and mission risks in the spaceflight environment. Methods: An extensive review of the literature and current aeromedical standards for the monitoring and management of renal stones was done. The NASA Flight Medicine Clinic's electronic medical record and Longitudinal Survey of Astronaut Health were also reviewed. Using this work, a screening and management algorithm was created that takes into consideration the unique operational environment of spaceflight. Results: Renal stone screening and management guidelines for astronauts were created based on accepted standards of care, with consideration to the environment of spaceflight. In the proposed algorithm, all astronauts will receive a yearly screening ultrasound for renal calcifications, or mineralized renal material (MRM). Any areas of MRM, 3 millimeters or larger, are considered a positive finding. Three millimeters approaches the detection limit of standard ultrasound, and several studies have shown that any stone that is 3 millimeters or less has an approximately 95 percent chance of spontaneous passage. For mission-assigned astronauts, any positive ultrasound study is followed by low-dose renal computed tomography (CT) scan, and flexible ureteroscopy if CT is positive. Other specific guidelines were also created. Discussion: The term "MRM" is used to account for small areas of calcification that may be outside the renal collecting system, and allows objectivity without otherwise constraining the diagnostic and treatment process for potentially very small calcifications of uncertain significance. However, a small asymptomatic MRM or stone within the renal collecting system may become symptomatic, and so affect launch and flight schedules, cause incapacitation during flight, and ultimately require medical evacuation. For exploration class missions, evacuation is unlikely. The new screening and management algorithm allows better management of mission risks, and will define the true incidence of renal stones in U.S. astronauts. This information will be used to refine future screening, countermeasures and treatment methods; and will also inform the needed capabilities to be flown on exploration-class missions.

Description: There are no specific guidelines for the management of renal stones in astronauts. Given the increased risk for bone loss, hypercalcuria, and stone formation due to microgravity, a clinical practice guideline is needed. Methods An extensive review of the literature and current aeromedical standards for the management of renal stones was done. The NASA Flight Medicine Clinic's electronic medical record and Longitudinal Survey of Astronaut Health were also reviewed. This information was used to create an algorithm for the management of renal stones in astronauts. Results Guidelines are proposed based on accepted standards of care, with consideration to the environment of spaceflight. In a usual medical setting, asymptomatic, small stones less than 7 mm are often observed over time. Given the constraints of schedule, and the risks to crew health and mission, this approach is too liberal. An upper limit of 3 mm stone diameter was adopted before requiring intervention, because this is the largest size that has a significant chance of spontaneous passage on its own. Other specific guidelines were also created. Discussion The spaceflight environment requires more aggressive treatment than would otherwise be found with the usual practice of medicine. A small stone can become a major problem because it may ultimately require medical evacuation from orbit. Thus renal stones are a significant mission threat and should be managed in a systematic way to mitigate risks to crew health and mission success.

Description: The Human Research Program funded the development of the Integrated Medical Model (IMM) to quantify the medical component of overall mission risk. The IMM uses Monte Carlo simulation methodology, incorporating space flight and ground medical data, to estimate the probability of mission medical outcomes and resource utilization. To determine the credibility of IMM output, the IMM project team completed two validation studies that compared IMM predicted output to observed medical events from a selection of Shuttle Transportation System (STS) and International Space Station (ISS) missions. The validation study results showed that the IMM underpredicted the occurrence of ~10% of the modeled medical conditions for the STS missions and overpredicted ~20% of the modeled medical conditions for the ISS missions. These findings imply that the strength of IMM predictions to inform decisions depends on simulated mission specifications including length. This discrepancy could result from medical recording differences between ISS and STS that possibly influence observed incidence rates, IMM combining all "mission type" data as constant occurrence rate or fixed proportion across both mission types, misspecification of symptoms to conditions, and gaps in the literature informing the model. Some of these issues will be alleviated by updating the IMM source data through incorporation of the observed validation data.

Description: Aerobic fitness is best measured by Maximal Aerobic Capacity or VO2 Max which is defined as a measure of oxygen utilization and transport. Increased Vo2 max indicates improved oxygen consumption during high level exercise and is widely accepted as a predictor of an individual's likelihood of successfully completing a demanding task. As such, agencies and organizations have adopted VO2 max as part of a comprehensive set of physical requirements. The purpose of this study is to review the literature and existing medical and occupational VO2 max data, to propose a VO2 max standard for NASA astronauts for training and spaceflight.

Description: Human exploration missions that reach destinations beyond low Earth orbit, such as Mars, will present significant new challenges to crew health management. For the medical system, lack of consumable resupply, evacuation opportunities, and real-time ground support are key drivers toward greater autonomy. Recognition of the limited mission and vehicle resources available to carry out exploration missions motivates the Exploration Medical Capability (ExMC) Element's approach to enabling the necessary autonomy. The Element's work must integrate with the overall exploration mission and vehicle design efforts to successfully provide exploration medical capabilities. ExMC is applying systems engineering principles and practices to accomplish its goals. This paper discusses the structured and integrative approach that is guiding the medical system technical development. Assumptions for the required levels of care on exploration missions, medical system goals, and a Concept of Operations are early products that capture and clarify stakeholder expectations. Model-Based Systems Engineering techniques are then applied to define medical system behavior and architecture. Interfaces to other flight and ground systems, and within the medical system are identified and defined. Initial requirements and traceability are established, which sets the stage for identification of future technology development needs. An early approach for verification and validation, taking advantage of terrestrial and near-Earth exploration system analogs, is also defined to further guide system planning and development.