85 research outputs found

    VIIRS On-Orbit Optical Anomaly - Investigation, Analysis, Root Cause Determination and Lessons Learned

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    A gradual, but persistent, decrease in the optical throughput was detected during the early commissioning phase for the Suomi National Polar-Orbiting Partnership (SNPP) Visible Infrared Imager Radiometer Suite (VIIRS) Near Infrared (NIR) bands. Its initial rate and unknown cause were coincidently coupled with a decrease in sensitivity in the same spectral wavelength of the Solar Diffuser Stability Monitor (SDSM) raising concerns about contamination or the possibility of a system-level satellite problem. An anomaly team was formed to investigate and provide recommendations before commissioning could resume. With few hard facts in hand, there was much speculation about possible causes and consequences of the degradation. Two different causes were determined as will be explained in this paper. This paper will describe the build and test history of VIIRS, why there were no indicators, even with hindsight, of an on-orbit problem, the appearance of the on-orbit anomaly, the initial work attempting to understand and determine the cause, the discovery of the root cause and what Test-As-You-Fly (TAYF) activities, can be done in the future to greatly reduce the likelihood of similar optical anomalies. These TAYF activities are captured in the lessons learned section of this paper

    Updated standardized definitions for efficacy endpoints in adjuvant breast cancer clinical trials: STEEP Version 2.0

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    Purpose The Standardized Definitions for Efficacy End Points (STEEP) criteria, established in 2007, provide standardized definitions of adjuvant breast cancer clinical trial end points. Given the evolution of breast cancer clinical trials and improvements in outcomes, a panel of experts reviewed the STEEP criteria to determine whether modifications are needed.Methods We conducted systematic searches of ClinicalTrials.gov for adjuvant systemic and local-regional therapy trials for breast cancer to investigate if the primary end points reported met STEEP criteria. On the basis of common STEEP deviations, we performed a series of simulations to evaluate the effect of excluding non-breast cancer deaths and new nonbreast primary cancers from the invasive disease-free survival end point.Results Among 11 phase III breast cancer trials with primary efficacy end points, three had primary end points that followed STEEP criteria, four used STEEP definitions but not the corresponding end point names, and four used end points that were not included in the original STEEP manuscript. Simulation modeling demonstrated that inclusion of second nonbreast primary cancer can increase the probability of incorrect inferences, can decrease power to detect clinically relevant efficacy effects, and may mask differences in recurrence rates, especially when recurrence rates are low.Conclusion We recommend an additional end point, invasive breast cancer-free survival, which includes all invasive disease-free survival events except second nonbreast primary cancers. This end point should be considered for trials in which the toxicities of agents are well-known and where the risk of second primary cancer is small. Additionally, we provide end point recommendations for local therapy trials, low-risk populations, noninferiority trials, and trials incorporating patient-reported outcomes

    Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial

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    Background Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy
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