100 research outputs found
Building a transdisciplinary expert consensus on the cognitive drivers of performance under pressure: an international multi-panel Delphi study.
The ability to perform optimally under pressure is critical across many occupations, including the military, first responders and competitive sport. Despite recognition that such performance depends on a range of cognitive factors, how common these factors are across performance domains remains unclear. The current study sought to integrate existing knowledge in the performance field in the form of a transdisciplinary expert consensus on the cognitive mechanisms that underlie performance under pressure. International experts were recruited from four performance domains: (i) defense; (ii) competitive sport; (iii) civilian high-stakes; and (iv) performance neuroscience. Experts rated constructs from the Research Domain Criteria (RDoC) framework (and several expert-suggested constructs) across successive rounds, until all constructs reached consensus for inclusion or were eliminated. Finally, included constructs were ranked for their relative importance. Sixty-eight experts completed the first Delphi round, with 94% of experts retained by the end of the Delphi process. The following 10 constructs reached consensus across all four panels (in order of overall ranking): (1) attention; (2) cognitive control-performance monitoring; (3) arousal and regulatory systems-arousal; (4) cognitive control-goal selection, updating, representation and maintenance; (5) cognitive control-response selection and inhibition/suppression; (6) working memory-flexible updating; (7) working memory-active maintenance; (8) perception and understanding of self-self-knowledge; (9) working memory-interference control; and (10) expert-suggested-shifting. Our results identify a set of transdisciplinary neuroscience-informed constructs, validated through expert consensus. This expert consensus is critical to standardizing cognitive assessment and informing mechanism-targeted interventions in the broader field of human performance optimization
Comparison of published core outcome sets with outcomes recommended in regulatory guidance from the US Food and Drug Administration and European Medicines Agency: cross sectional analysis
ObjectiveTo compare the outcomes in published core outcome sets with the outcomes recommended in corresponding guidance documents from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), matched by health condition.DesignCross sectional analysis.SettingUS and Europe.PopulationSample of core outcome sets related to drugs, devices, and gene therapy that involved patients in the consensus process, published between 1 January 2015 and 31 December 2019; and corresponding EMA and FDA guidance documents.Main outcome measuresThe extent of matches between outcomes included within core outcome sets and those recommended in corresponding EMA and FDA guidance documents were assessed. Matches were considered to be general (ie, non-specific) or specific (ie, exact). General matches were assessed to determine whether the core outcome set or guidance document outcome was narrower.ResultsRelevant guidance documents were found for for 38 (39%) of 98 eligible published core outcome sets. Among outcomes in core outcome sets, medians of 70% (interquartile range 48-86%) and 52% (33-77%) were matches with outcomes recommended in EMA and FDA documents, respectively. Medians of 46% (27-68%) and 26% (18-46%) were specific matches with outcomes in EMA and FDA documents, respectively. When outcomes were generally matched, the outcomes from core outcome sets were more frequently narrower than the regulatory outcomes (83% and 75% for EMA and FDA, respectively).ConclusionGreater adoption of, and reference to, core outcome sets in regulatory guidance documents can encourage clinical trialists, especially those in industry, to measure and report consistent and agreed outcomes and improve the quality of guidance. Given the overlap between outcomes in core outcome sets and regulatory guidance, and given that most core outcome sets now involve patients in the consensus process, these sets could serve as a useful resource for regulators when recommending outcomes for studies evaluating regulated products. Developers are encouraged to appraise recommended outcomes in salient regulatory documents when planning a core outcome set
Pneumococcal carriage, serotype distribution, and antimicrobial susceptibility in Papua New Guinean children vaccinated with PCV10 or PCV13 in a head-to-head trial
Background: Children in Papua New Guinea (PNG) are at high risk of pneumococcal infections. We investigated pneumococcal carriage rates, serotype distribution, and antimicrobial susceptibility in PNG children after vaccination with 10-valent or 13-valent pneumococcal conjugate vaccines (PCV10; PCV13). Methods: Infants (N = 262) were randomized to receive 3 doses of PCV10 or PCV13 at 1-2-3 months of age, followed by pneumococcal polysaccharide vaccination (PPV) or no PPV at 9 months of age. Nasopharyngeal swabs (NPS) collected at ages 1, 4, 9, 10, 23 and 24 months were cultured using standard bacteriological procedures. Morphologically distinct Streptococcus pneumoniae colonies were serotyped by the Quellung reaction. Antimicrobial susceptibility was determined by Kirby-Bauer disc diffusion and minimum inhibitory concentration (MIC). Results: S. pneumoniae was isolated from 883/1063 NPS collected at 1–23 months of age, including 820 serotypeable (64 different serotypes) and 144 non-serotypeable isolates. At age 23 months, 93.6% (95%CI 86.6–97.6%) of PCV10 recipients and 88.6% (95%CI 80.1–94.4%) of PCV13 recipients were pneumococcal carriers, with higher carriage of PCV10 serotypes by PCV10 recipients (19.8%, 95%CI 12.2–29.5) than PCV13 recipients (9.3%, 95%CI 4.1–17.3) (p = 0.049). There were no other statistically significant differences between PCV10 and PCV13 recipients and children receiving PPV or no PPV. Nearly half (45.6%) of carried pneumococci were non-susceptible to penicillin based on the meningitis breakpoint (MI
Revealing the former bed of Thwaites Glacier using sea-floor bathymetry: Implications for warm-water routing and bed controls on ice flow and buttressing
Abstract. The geometry of the sea floor immediately beyond
Antarctica's marine-terminating glaciers is a fundamental control on
warm-water routing, but it also describes former topographic pinning points
that have been important for ice-shelf buttressing. Unfortunately, this
information is often lacking due to the inaccessibility of these areas for
survey, leading to modelled or interpolated bathymetries being used as
boundary conditions in numerical modelling simulations. At Thwaites Glacier
(TG) this critical data gap was addressed in 2019 during the first cruise of
the International Thwaites Glacier Collaboration (ITGC) project. We present more than 2000 km2 of new multibeam
echo-sounder (MBES) data acquired in exceptional sea-ice conditions
immediately offshore TG, and we update existing bathymetric compilations.
The cross-sectional areas of sea-floor troughs are under-predicted by up to
40 % or are not resolved at all where MBES data are missing, suggesting that
calculations of trough capacity, and thus oceanic heat flux, may be
significantly underestimated. Spatial variations in the morphology of
topographic highs, known to be former pinning points for the floating ice
shelf of TG, indicate differences in bed composition that are supported by
landform evidence. We discuss links to ice dynamics for an overriding ice
mass including a potential positive feedback mechanism where erosion of
soft erodible highs may lead to ice-shelf ungrounding even with little
or no ice thinning. Analyses of bed roughnesses and basal drag contributions
show that the sea-floor bathymetry in front of TG is an analogue for extant
bed areas. Ice flow over the sea-floor troughs and ridges would have been
affected by similarly high basal drag to that acting at the grounding zone
today. We conclude that more can certainly be gleaned from these 3D
bathymetric datasets regarding the likely spatial variability of bed
roughness and bed composition types underneath TG. This work also addresses
the requirements of recent numerical ice-sheet and ocean modelling studies
that have recognised the need for accurate and high-resolution bathymetry to
determine warm-water routing to the grounding zone and, ultimately, for
predicting glacier retreat behaviour.
</jats:p
Investigation of CTBT OSI Radionuclide Techniques at the DILUTED WATERS Nuclear Test Site
Under the Comprehensive Nuclear-Test-Ban Treaty (CTBT), a verification regime that includes the ability to conduct an On-Site Inspection (OSI) will be established. The Treaty allows for an OSI to include many techniques, including the radionuclide techniques of gamma radiation surveying and spectrometry and environmental sampling and analysis. Such radioactivity detection techniques can provide the “smoking gun” evidence that a nuclear test has occurred through the detection and quantification of indicative recent fission products. An OSI faces restrictions in time and manpower, as dictated by the Treaty; not to mention possible logistics difficulties due to the location and climate of the suspected explosion site. It is thus necessary to have a good understanding of the possible source term an OSI will encounter and the proper techniques that will be necessary for an effective OSI regime. One of the challenges during an OSI is to locate radioactive debris that has escaped an underground nuclear explosion (UNE) and settled on the surface near and downwind of ground zero. To support the understanding and selection of sampling and survey techniques for use in an OSI, we are currently designing an experiment, the Particulate Release Experiment (PRex), to simulate a small-scale vent from an underground nuclear explosion. PRex will occur at the Nevada National Security Site (NNSS). The project is conducted under the National Center for Nuclear Security (NCNS) funded by the National Nuclear Security Agency (NNSA). Prior to the release experiment, scheduled for Spring of 2013, the project scheduled a number of activities at the NNSS to prepare for the release experiment as well as to utilize the nuclear testing past of the NNSS for the development of OSI techniques for CTBT. One such activity—the focus of this report—was a survey and sampling campaign at the site of an old UNE that vented: DILUTED WATERS. Activities at DILUTED WATERS included vehicle-based survey, in situ measurements with high-purity germanium (HPGe) and hand-held LaBr3 systems, soil sampling with a variety of tools, and laboratory gamma spectrometric analysis of those samples. A further benefit of the measurement campaign was to gain familiarity with the many logistical aspects of performing radiological field work at NNSS ahead of the PRex. Many practical lessons concerning the proper methodologies and logistics of using the surveying and sampling equipment were noted. These Lessons Learned are compiled together in Appendix A. The vehicle-based survey was successful in that it found a previously unknown hotspot (determined to be 232Th) while it demonstrated that a better method for keeping a serpentine track without staking was needed. Some of the soil sampling equipment was found to be impractical for the application, though core sampling would not be the correct way to take soil samples for a fresh vent deposit (as opposed to an old site like DILUTED WATERS). Due to the site’s age, 137Cs was the only fission radioisotope identified, though others were searched for. While not enough samples were taken and analyzed to definitively link the 137Cs to DILUTED WATERS as opposed to other NNSS activities, results were consistent with the historical DILUTED WATERS plume. MDAs were compared for soil sampling and in situ measurements
Safety and immunogenicity of pneumococcal conjugate vaccines in a high-risk population : A randomized controlled trial of 10-valent and 13-valent pneumococcal conjugate vaccine in Papua New Guinean infants
Background. There are little data on the immunogenicity of PCV10 and PCV13 in the same high-risk population. Methods. PCV10 and PCV13 were studied head-to-head in a randomized controlled trial in Papua New Guinea in which 262 infants received 3 doses of PCV10 or PCV13 at 1, 2, and 3 months of age. Serotype-specific immunoglobulin G (IgG) concentrations, and pneumococcal and nontypeable Haemophilus influenzae (NTHi) carriage were assessed prevaccination and at 4 and 9 months of age. Infants were followed up for safety until 9 months of age. Results. One month after the third dose of PCV10 or PCV13, 80% of infants had IgG concentrations ≥0.35µg/mL for vaccine serotypes, and 6 months postvaccination IgG concentrations ≥0.35 µg/mL were maintained for 8/10 shared PCV serotypes in > 75% of children vaccinated with either PCV10 or PCV13. Children carried a total of 65 different pneumococcal serotypes (plus nonserotypeable). At 4 months of age, 92% (95% confidence interval [CI] 85–96) of children vaccinated with PCV10 and 81% (95% CI 72–88) vaccinated with PCV13 were pneumococcal carriers (P = .023), whereas no differences were seen at 9 months of age, or for NTHi carriage. Both vaccines were well tolerated and not associated with serious adverse events. Conclusions. Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed. Clinical Trials Registration. NCT01619462
- …