33 research outputs found
Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial
Background:
Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19.
Methods:
This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.
Findings:
Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79).
Interpretation:
In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes.
Funding:
UK Research and Innovation (Medical Research Council) and National Institute of Health Research
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Training and qualification program for nuclear criticality safety technical staff
A training and qualification program for nuclear criticality safety technical staff personnel has been developed and implemented. The program is compliant with requirements and provides evidence that a systematic approach has been taken to indoctrinate new technical staff. Development involved task analysis to determine activities where training was necessary and the standard which must be attained to qualify. Structured mentoring is used where experienced personnel interact with candidates using checksheets to guide candidates through various steps and to provide evidence that steps have been accomplished. Credit can be taken for the previous experience of personnel by means of evaluation boards which can credit or modify checksheet steps. Considering just the wealth of business practice and site specific information a new person at a facility needs to assimilate, the program has been effective in indoctrinating new technical staff personnel and integrating them into a productive role. The program includes continuing training
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Training and qualification program for nuclear criticality safety technical staff. Revision 1
A training and qualification program for nuclear criticality safety technical staff personnel has been developed and implemented. All personnel who are to perform nuclear criticality safety technical work are required to participate in the program. The program includes both general nuclear criticality safety and plant specific knowledge components. Advantage can be taken of previous experience for that knowledge which is portable such as performance of computer calculations. Candidates step through a structured process which exposes them to basic background information, general plant information, and plant specific information which they need to safely and competently perform their jobs. Extensive documentation is generated to demonstrate that candidates have met the standards established for qualification
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Nuclear Criticality Safety Organization guidance for the development of continuing technical training. Revision 1
The Nuclear Criticality Safety Organization (NCSO) is committed to developing and maintaining a staff of highly qualified personnel to meet the current and anticipated needs in nuclear criticality safety at the Oak Ridge Y-12 Plant and throughout the DOE complex. Continuing technical training is training outside of the initial qualification program to address identified organization-wide needs. Typically, this training is used to improve organization performance in the conduct of business. This document provides guidelines for the development of the technical portions of the Continuing Training Program. It is not a step-by-step procedure, but a collection of considerations to be used during the development process
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Nuclear criticality safety department training implementation
The Nuclear Criticality Safety Department (NCSD) is committed to developing and maintaining a staff of qualified personnel to meet the current and anticipated needs in Nuclear Criticality Safety (NCS) at the Oak Ridge Y-12 Plant. The NCSD Qualification Program is described in Y/DD-694, Qualification Program, Nuclear Criticality Safety Department This document provides a listing of the roles and responsibilities of NCSD personnel with respect to training and details of the Training Management System (TMS) programs, Mentoring Checklists and Checksheets, as well as other documentation utilized to implement the program. This document supersedes Y/DD-696, Revision 2, dated 3/27/96, Training Implementation, Nuclear Criticality Safety Department. There are no backfit requirements associated with revisions to this document
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Nuclear Criticality Safety Department Qualification Program
The Nuclear Criticality Safety Department (NCSD) is committed to developing and maintaining a staff of highly qualified personnel to meet the current and anticipated needs in Nuclear Criticality Safety (NCS) at the Oak Ridge Y-12 Plant. This document defines the Qualification Program to address the NCSD technical and managerial qualification as required by the Y-1 2 Training Implementation Matrix (TIM). This Qualification Program is in compliance with DOE Order 5480.20A and applicable Lockheed Martin Energy Systems, Inc. (LMES) and Y-1 2 Plant procedures. It is implemented through a combination of WES plant-wide training courses and professional nuclear criticality safety training provided within the department. This document supersedes Y/DD-694, Revision 2, 2/27/96, Qualification Program, Nuclear Criticality Safety Department There are no backfit requirements associated with revisions to this document
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Nuclear Criticality Safety Organization training implementation. Revision 4
The Nuclear Criticality Safety Organization (NCSO) is committed to developing and maintaining a staff of qualified personnel to meet the current and anticipated needs in Nuclear Criticality Safety (NCS) at the Oak Ridge Y-12 Plant. This document provides a listing of the roles and responsibilities of NCSO personnel with respect to training and details of the Training Management System (TMS) programs, Mentoring Checklists and Checksheets, as well as other documentation utilized to implement the program. This Training Implementation document is applicable to all technical and managerial NCSO personnel, including temporary personnel, sub-contractors and/or LMES employees on loan to the NCSO, who are in a qualification program
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Nuclear Criticality Safety Organization qualification program. Revision 4
The Nuclear Criticality Safety Organization (NCSO) is committed to developing and maintaining a staff of highly qualified personnel to meet the current and anticipated needs in Nuclear Criticality Safety (NCS) at the Oak Ridge Y-12 Plant. This document defines the Qualification Program to address the NCSO technical and managerial qualification as required by the Y-12 Training Implementation Matrix (TIM). It is implemented through a combination of LMES plant-wide training courses and professional nuclear criticality safety training provided within the organization. This Qualification Program is applicable to technical and managerial NCSO personnel, including temporary personnel, sub-contractors and/or LMES employees on loan to the NCSO, who perform the NCS tasks or serve NCS-related positions as defined in sections 5 and 6 of this program
The archaeology of human-bird interactions : essays in honour of Dale Serjeantson part II
Editorial