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result(s) for
"Bevan, Simon"
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Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?
by
Gillies, Katie
,
Bevan, Simon
,
Bower, Peter
in
Biomedicine
,
Clinical Decision-Making
,
Clinical trials
2018
Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiative that aims to increase the evidence base for trial decision-making and in doing so, to improve trial efficiency.
One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This guidance document provides a brief definition of SWATs, an explanation of why they are important and some practical ‘top tips’ that come from existing experience of doing SWATs. We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one.
Journal Article
Reassessment of the taxonomic position of Burkholderia andropogonis and description of Robbsia andropogonis gen. nov., comb. nov
by
Ferreira-Tonin, Mariana
,
Weir, Bevan Simon
,
Ottoboni, Laura Maria Mariscal
in
Bacteria
,
Bacterial Typing Techniques
,
Biomedical and Life Sciences
2017
The phylogenetic classification of the species
Burkholderia andropogonis
within the
Burkholderia
genus was reassessed using 16S rRNA gene phylogenetic analysis and multilocus sequence analysis (MLSA). Both phylogenetic trees revealed two main groups, named A and B, strongly supported by high bootstrap values (100%). Group A encompassed all of the
Burkholderia
species complex, whi.le Group B only comprised
B. andropogonis
species, with low percentage similarities with other species of the genus, from 92 to 95% for 16S rRNA gene sequences and 83% for conserved gene sequences. Average nucleotide identity (ANI), tetranucleotide signature frequency, and percentage of conserved proteins POCP analyses were also carried out, and in the three analyses
B. andropogonis
showed lower values when compared to the other
Burkholderia
species complex, near 71% for ANI, from 0.484 to 0.724 for tetranucleotide signature frequency, and around 50% for POCP, reinforcing the distance observed in the phylogenetic analyses. Our findings provide an important insight into the taxonomy of
B. andropogonis
. It is clear from the results that this bacterial species exhibits genotypic differences and represents a new genus described herein as
Robbsia andropogonis
gen. nov., comb. nov.
Journal Article
Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed
by
Gillies, Katie
,
Bevan, Simon
,
Galvin, Sandra
in
Biomedicine
,
Clinical Decision-Making
,
Clinical trials
2020
The evidence base available to trialists to support trial process decisions—e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants—is thin. One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. These are self-contained research studies embedded within a host trial that aim to evaluate or explore alternative ways of delivering or organising a particular trial process.
SWATs are increasingly being supported by funders and considered by trialists, especially in the UK and Ireland. At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial? A framework for answering such a question is needed to avoid SWATs themselves contributing to research waste.
This paper presents criteria on when enough evidence is available for SWATs that use randomised allocation to compare different interventions.
Journal Article
Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study
by
Treweek, Shaun P.
,
Duley, Lelia
,
Walker, Kate
in
Analysis
,
Biomedicine
,
Building capacity for evidence informed trial management
2018
Background
Site performance is key to the success of large multicentre randomised trials. A standardised set of clear and accessible summaries of site performance could facilitate the timely identification and resolution of potential problems, minimising their impact.
The aim of this study was to identify and agree a core set of key performance metrics for managing multicentre randomised trials.
Methods
We used a mixed methods approach to identify potential metrics and to achieve consensus about the final set, adapting methods that are recommended by the COMET Initiative for developing core outcome sets in health care.
We used performance metrics identified from our systematic search and focus groups to create an online Delphi survey. We invited respondents to score each metric for inclusion in the final core set, over three survey rounds. Metrics scored as critical by ≥70% and unimportant by <15% of respondents were taken forward to a consensus meeting of representatives from key UK-based stakeholders. Participants in the consensus meeting discussed and voted on each metric, using anonymous electronic voting. Metrics with >50% of participants voting for inclusion were retained.
Results
Round 1 of the Delphi survey presented 28 performance metrics, and a further six were added in round 2. Of 294 UK-based stakeholders who registered for the Delphi survey, 211 completed all three rounds.
At the consensus meeting, 17 metrics were discussed and voted on: 15 metrics were retained following survey round 3, plus two others that were preferred by consensus meeting participants. Consensus was reached on a final core set of eight performance metrics in three domains: (1) recruitment and retention, (2) data quality and (3) protocol compliance. A simple tool for visual reporting of the metrics is available from the Nottingham Clinical Trials Unit website.
Conclusions
We have established a core set of metrics for measuring the performance of sites in multicentre randomised trials. These metrics could improve trial conduct by enabling researchers to identify and address problems before trials are adversely affected. Future work could evaluate the effectiveness of using the metrics and reporting tool.
Journal Article
Developing an institutional repository: Cranfield QUEprints - a case study
2007
Purpose - The purpose of this paper is to describe the development of the Institutional Repository at Cranfield University - Cranfield QUEprints (http://dspace.lib.cranfield.ac.uk). Design/methodology/approach - The paper describes the methodologies involved in acquiring research output, and covers advocacy strategies, policies, and also provides data on cost and usage. Findings - The Cranfield QUEprints is a managed repository where the archiving is undertaken by library staff. This has proved to be a successful method of acquiring research outputs and increasing content. Selected methods of persuading academics to contribute to the IR, including personal contact, and marketing information, have also proved successful. Research limitations/implications - That the report is specific to an institution, but provides experiences that will be generally applicable. Originality/value - The paper provides reassurance that, when it comes to populating an institutional repository, an alternative method to self-archiving can be successful and cost-effective. It is hoped that the descriptions provided in the paper will provide encouragement to institutions currently without an IR that there are no insurmountable barriers to the development of such a system.
Journal Article
Honesty is the best policy
2008
The cost of fraud prevention has to be balanced against savings and the ability to be 'fleet-footed' in your business dealings. What you can do is put trip wires in place so that you know within weeks, not months, that you have been defrauded. You can also reduce your risk profile. Organizations need to take a risk-based approach to the due diligence they carry out prior to recruitment. Many people do not have faith in written references. Some employers are afraid of the perceived litigation risk of giving an adverse reference. No one has been sued for an adverse reference.
Trade Publication Article
Bargaining power
2006
The government has recently released its fraud review report for consultation. Of particular interest is the call for stiffer sentences for those convicted of fraud offences. But, the threat of stiffer sentences may be reduced by another suggestion made in the review. A proposal to introduce plea bargaining is recommended and this is made on the basis that current fraud investigations and trials are extremely time-consuming. While there are obvious advantages to plea bargaining (justice is served quickly and victims can be compensated), it seems somewhat contradictory to propose stiffer sentences but then introduce a mechanism which allows defendants to enter a guilty plea and then bargain on the sentence they receive.
Trade Publication Article