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Search indexed NASA NTRS and DOE OSTI research on propulsion, heat transfer, battery materials and energy systems. Follow report and document links to the original sources.

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All sourcesNASA NTRSDOE OSTI
DOE OSTI2021

Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective

Pediatric patient-reported outcome (PRO) data can help inform the US Food and Drug Administration’s (FDA’s) benefit-risk assessment of cancer therapeutics by quantifying symptom and functional outcomes from the patient’s perspective. This study assessed use of PROs in commercial pediatric oncology trials submitted to the FDA for regulatory review. FDA databases were searched to identify pediatric oncology product applications approved between 1997 and 2020. Sponsor-submitted documents were reviewed to determine whether PRO data were collected, which instruments were used, and the quality of collected data (ie, sample size, completion rates, and use of fit-for-purpose instruments). The role of PROs in each trial (endpoint hierarchy) was also recorded in addition to whether any PRO endpoints were included in product labeling. We reviewed 17 pediatric oncology applications, 4 of which included PRO data: denosumab, tisagenlecleucel, larotrectinib, and selumetinib. In these 4 instances, PROs served as exploratory endpoints and were not incorporated in product labeling. Trials that collected PRO data were phase II or phase I/II single-arm studies with sample sizes of 28 to 88 patients. Symptomatic adverse events (AEs) were characterized using clinician-reported Common Terminology Criteria for Adverse Events (CTCAE) without additional patient self-report. PROs were infrequently used in pediatric cancer registration trials. When PROs were used, PRO data were limited by lack of a clear research objective and corresponding prospective statistical analysis plan. Contemporary PRO symptom libraries, such as the National Cancer Institute’s Pediatric PRO-CTCAE, may provide an opportunity to better evaluate the occurrence and impact of symptomatic AEs, from the patient’s perspective, in pediatric oncology trials.

Oncology↗
DOE OSTI2020

Development and validation of a 30-day mortality index based on pre-existing medical administrative data from 13,323 COVID-19 patients: The Veterans Health Administration COVID-19 (VACO) Index

Background Available COVID-19 mortality indices are limited to acute inpatient data. Using nationwide medical administrative data available prior to SARS-CoV-2 infection from the US Veterans Health Administration (VA), we developed the VA COVID-19 (VACO) 30-day mortality index and validated the index in two independent, prospective samples. Methods and findings We reviewed SARS-CoV-2 testing results within the VA between February 8 and August 18, 2020. The sample was split into a development cohort (test positive between March 2 and April 15, 2020), an early validation cohort (test positive between April 16 and May 18, 2020), and a late validation cohort (test positive between May 19 and July 19, 2020). Our logistic regression model in the development cohort considered demographics (age, sex, race/ethnicity), and pre-existing medical conditions and the Charlson Comorbidity Index (CCI) derived from ICD-10 diagnosis codes. Weights were fixed to create the VACO Index that was then validated by comparing area under receiver operating characteristic curves (AUC) in the early and late validation cohorts and among important validation cohort subgroups defined by sex, race/ethnicity, and geographic region. We also evaluated calibration curves and the range of predictions generated within age categories. 13,323 individuals tested positive for SARS-CoV-2 (median age: 63 years; 91% male; 42% non-Hispanic Black). We observed 480/3,681 (13%) deaths in development, 253/2,151 (12%) deaths in the early validation cohort, and 403/7,491 (5%) deaths in the late validation cohort. Age, multimorbidity described with CCI, and a history of myocardial infarction or peripheral vascular disease were independently associated with mortality–no other individual comorbid diagnosis provided additional information. The VACO Index discriminated mortality in development (AUC = 0.79, 95% CI: 0.77–0.81), and in early (AUC = 0.81 95% CI: 0.78–0.83) and late (AUC = 0.84, 95% CI: 0.78–0.86) validation. The VACO Index allows personalized estimates of 30-day mortality after COVID-19 infection. For example, among those aged 60–64 years, overall mortality was estimated at 9% (95% CI: 6–11%). The Index further discriminated risk in this age stratum from 4% (95% CI: 3–7%) to 21% (95% CI: 12–31%), depending on sex and comorbid disease. Conclusion Prior to infection, demographics and comorbid conditions can discriminate COVID-19 mortality risk overall and within age strata. The VACO Index reproducibly identified individuals at substantial risk of COVID-19 mortality who might consider continuing social distancing, despite relaxed state and local guidelines.

60 APPLIED LIFE SCIENCES↗
NASA NTRS1986

Summary Report of the NASA Management Study Group: Recommendations to the Administrator, National Aeronautics and Space Administration

The NASA Management Study Group (NMSG) was established under the auspices of the National Acedamy of Public Administration at the request of the Administrator of NASA to assess NASA's management practices and to evaluate the effectiveness of the NASA organization. This report summarizes the conclusions and recommendations of the NMSG on the overall management and organization of NASA.

Phillips, Samuel C.↗
NASA NTRS1967

Report of Apollo 204 Review Board to the Administrator, National Aeronautics and Space Administration : Schedule of Physical Evidence - Appendix F

Immediately following the Apollo 204 accident of January 27, 1961. all associated equipment and material were impounded. Release of this equipment and material for normal use was under the close control of the Apollo 204 Review Board. Apollo Review Board Administrative Procedure No. 11, February 11, 1961, established the Apollo 204 Review Board Material Release Record (MRR). This MRR was the official form used to release material from full impoundment and was valid only after being approved by the Board and signed by a Member. The form was used as the authority to place any impounded item into one of the three Categories defined in Administrative Procedure No. 11. This appendix contains all of the authorized MRR's. Each item submitted on an MRR was given a control number; a description, including the part number and serial number; the relevance and location to the accident; any constraints before release; and the control category. The categories placed on the equipment were as follows: Category A - Items which may have a significant influence or bearing on the results or findings of the Apollo 204 Review Board; Category B - All material other than Category A which is considered relevant to the Apollo 204 Review Board investigation; Category C - Material released from Board jurisdiction. Several classes of equipment were released by special Board action prior to the establishment of the MRR system. The operating procedure for release of these classes is Enclosure F-l to this appendix.

Source record↗
NASA NTRS2021

Subcommittee on Space and Aeronautics Committee on Science, Space, and Technology: Statement by Dr. Gavin A. Schmidt Senior Advisor on Climate to the Administrator (Acting) National Aeronautics and Space Administration 117th Congress

NASA has long recognized that climate science and climate change are fundamental parts of our mandate, and for decades we have worked on fundamental and applied research in these areas. With the increasing evidence for serious impacts and the elevation of this topic by the Administration, it is time for a renewed focus on all the aspects of climate change that NASA works on and a commitment to ensure that the data and understanding that NASA has and will continue to accumulate will be used for the benefit of society.

Gavin A Schmidt↗
NASA NTRS1978

Statement of Doctor Robert A. Frosch, Administrator, National Aeronautics and Space Administration

Short term views must be taken in order to concentrate on the foundations and steps to be followed in the next 10 years so that the need for, economics, and tangible values of long range dreams can be fully understood. Although the technological basis for many projected applications already exist, there is difficulty in obtaining funding for the initial steps toward the realization of any venture unless a quantitative basis can be demonstrated for the costs and benefits to be achieved. Computations are exaggerated for space systems because of their extreme front-end capitalization problems. The investment for satellite solar-powered satellite systems is comparable in magnitude to that contemplated for other energy systems, although there is a difference in the economics of the problem and in the technologies of the problem.

Frosch, R. A.↗
NASA NTRS1978

Statement of Doctor Noel Hinners, Associate Administrator for Space Sciences, National Aeronautics and Space Administration

Leadership in space exploration is an important part of the nation's prestige. There is a large science component in what are called applications and visa versa. Space science can provide the basis for some of the steps and bridges to possibilities envisioned for the year 2000 and forward. Both chemistry and physics are basis priorities in NASA missions and research activities. Current programs are concerned with developing the capability to put more weight in space, to provide for revisiting facilities such as the space telescope and provide for on-orbit repair or retrieval. Programs requiring the construction of facilities in space require higher levels of energy than those currently available. The prospective development of low-thrust propulsion in the 1980's will reduce transportation time. Data from Skylab and that to be obtained from Spacelab as well as investigations of solar-terrestrial interactions will benefit space tourists and inhabitants.

Hinners, N.↗