BSE risk assessments in the UK: a risk tradeoff?

2006 ◽  
Vol 100 (3) ◽  
pp. 417-427 ◽  
Author(s):  
P. Gale
Keyword(s):  
Risk Assessments ◽  
The Uk

scholarly journals An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Daniel Beever ◽  
Lizzie Swaby
Keyword(s):  
Risk Assessment ◽  
Clinical Trials ◽  
Perceived Risk ◽  
Online Survey ◽  
Research Collaboration ◽  
Good Clinical Practice ◽  
Risk Assessments ◽  
Risk Level ◽  
Pragmatic Trials ◽  
The Uk

Abstract Background Good Clinical Practice guidelines issued in 2016 encourage risk-based approaches to monitoring clinical trials. This study compared current risk assessment and monitoring approaches in UK Clinical Trials Units (CTUs) with the published guidance and makes recommendations for risk-based monitoring in pragmatic trials. Methods An online survey of UK Clinical Research Collaboration registered CTUs was administered via email invitation. Forty-nine units were invited, and 23 responded. Respondents were also invited to share copies of risk assessment templates. Results Most CTUs reported using remote combined with on-site monitoring. All reported undertaking a risk assessment for Clinical Trials of Investigational Medicinal Products (CTIMPs) and 21 units did so for non-CTIMPs. Most CTIMP risk assessments used MHRA (Medicines and Healthcare products Regulatory Agency) classifications, although some also employed staff judgement. Almost all units based their monitoring on perceived risk level; this number was higher for CTIMPs (n = 22) than for non-CTIMPs (n = 19). In most cases, monitoring plans were produced. More CTUs revisited risk assessments during trials in CTIMPs (n = 21) than in non-CTIMPs (n = 18). Small numbers of units reviewed the monitoring approach always (n = 4) or sometimes (n = 9) and few used the reflection to guide future monitoring. Conclusions A high proportion of UK CTUs are using risk-based monitoring in the UK, as recommended by guidelines, for both CTIMPs and non-CTIMPs. This has the potential to make trials more efficient and reduce costs. However, there appears to be a lack of reflection on the value of these revised approaches. There may be a benefit in CTUs collaborating nationally to improve processes for reflection and making changes during the life course of a trial.

Reduction Factors for Estimating the Probability of Failure of Mechanical Damage Due to External Interference

2008 ◽  
Author(s):  
Andrew Cosham ◽  
Jane Haswell ◽  
Neil Jackson
Keyword(s):  
Structural Reliability ◽  
Historical Data ◽  
Mechanical Damage ◽  
Probability Of Failure ◽  
Risk Assessments ◽  
External Interference ◽  
Failure Data ◽  
Major Accident ◽  
The Uk ◽  
Reduction Factors

Quantified risk assessments (QRAs) are widely used in the UK to assess the significance of the risk posed by major accident hazard pipelines on the population and infrastructure in the vicinity of the pipeline. A QRA requires the calculation of the frequency of failures and the consequences of failures. One of the main causes of failures in onshore pipelines is mechanical damage due to external interference, such as a dent, a gouge, or a dent and gouge. In the published literature, two methods have been used to calculate the probability of failure due to external interference: • historical failure data and • limit state functions combined with historical data (i.e. structural reliability-based methods). Structural reliability-based methods are mathematically complicated, compared to using historical failure data, but have several advantages, e.g. extrapolation beyond the limited historical data, and the identification of trends that may not be apparent in the historical data. In view of this complexity, proposed supplements to the UK pipeline design codes IGE/TD/1 (natural gas) and PD 8010 (all substances) — on the application of QRAs to proposed developments in the vicinity of major accident hazard pipelines — include simple ‘reduction factors’ for use in ‘screening’ risk assessments. These ‘reduction factors’ are based on a comprehensive parametric study using a structural reliability-based model to calculate the probability of failure due to mechanical damage, defined as: gouges, and dents and gouges. The two ‘reduction factors’ are expressed in terms of the design factor and wall thickness of the pipeline. It is shown that, through appropriate normalisation, the effects of diameter, grade and toughness are secondary. Reasonably accurate, but conservative, estimates of the probability of failure can be obtained using these ‘reduction factors’. The proposed methodology is considerably simpler than a structural reliability-based analysis. The development and verification of these ‘reduction factors’ is described in this paper.

scholarly journals Drumming-associated anthrax incidents: exposures to low levels of indoor environmental contamination

2018 ◽  
Vol 146 (12) ◽  
pp. 1519-1525 ◽  
Author(s):  
E. Bennett ◽  
I. M. Hall ◽  
T. Pottage ◽  
N.J. Silman ◽  
A.M. Bennett
Keyword(s):  
Environmental Contamination ◽  
Environmental Data ◽  
Risk Assessments ◽  
Incident Management ◽  
Low Level ◽  
Work Spaces ◽  
The Usa ◽  
Low Levels ◽  
Contamination Levels ◽  
The Uk

AbstractTwo fatal drumming-related inhalational anthrax incidents occurred in 2006 and 2008 in the UK. One individual was a drum maker and drummer from the Scottish Borders, most likely infected whilst playing a goat-skin drum contaminated with Bacillus anthracis spores; the second, a drummer and drum maker from East London, likely became infected whilst working with contaminated animal hides.We have collated epidemiological and environmental data from these incidents and reviewed them alongside three similar contemporaneous incidents in the USA. Sampling operations recovered the causative agent from drums and drum skins and from residences and communal buildings at low levels. From these data, we have considered the nature of the exposures and the number of other individuals likely to have been exposed, either to the primary infection events or to subsequent prolonged environmental contamination (or both).Despite many individual exposures to widespread low-level spore contamination in private residences and in work spaces for extended periods of time (at least 1 year in one instance), only one other individual acquired an infection (cutaneous). Whilst recognising the difficulty in making definitive inferences from these incidents to specific residual contamination levels, and by extending the risk to public health, we believe it may be useful to reflect on these findings when considering future incident management risk assessments and decisions in similar incidents that result in low-level indoor contamination.

scholarly journals Risk assessment and antibiotic prescribing decisions in children presenting to UK primary care with cough: a vignette study

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e035761
Author(s):  
Martine Nurek ◽  
Brendan C Delaney ◽  
Olga Kostopoulou
Keyword(s):  
Risk Assessment ◽  
Primary Care ◽  
Prediction Rule ◽  
Clinical Prediction Rule ◽  
Decision Makers ◽  
Risk Assessments ◽  
Antibiotic Prescribing ◽  
Illness Duration ◽  
Clinical Vignettes ◽  
The Uk

ObjectivesThe validated ‘STARWAVe’ (Short illness duration, Temperature, Age, Recession, Wheeze, Asthma, Vomiting) clinical prediction rule (CPR) uses seven variables to guide risk assessment and antimicrobial stewardship in children presenting with cough. We aimed to compare general practitioners’ (GPs) risk assessments and prescribing decisions to those of STARWAVe and assess the influence of the CPR’s clinical variables.SettingPrimary care.Participants252 GPs, currently practising in the UK.DesignGPs were randomly assigned to view four (of a possible eight) clinical vignettes online. Each vignette depicted a child presenting with cough, who was described in terms of the seven STARWAVe variables. Systematically, we manipulated patient age (20 months vs 5 years), illness duration (3 vs 6 days), vomiting (present vs absent) and wheeze (present vs absent), holding the remaining STARWAVe variables constant.Outcome measuresPer vignette, GPs assessed risk of hospitalisation and indicated whether they would prescribe antibiotics or not.ResultsGPs overestimated risk of hospitalisation in 9% of vignette presentations (88/1008) and underestimated it in 46% (459/1008). Despite underestimating risk, they overprescribed: 78% of prescriptions were unnecessary relative to GPs’ own risk assessments (121/156), while 83% were unnecessary relative to STARWAVe risk assessments (130/156). All four of the manipulated variables influenced risk assessments, but only three influenced prescribing decisions: a shorter illness duration reduced prescribing odds (OR 0.14, 95% CI 0.08 to 0.27, p<0.001), while vomiting and wheeze increased them (ORvomit 2.17, 95% CI 1.32 to 3.57, p=0.002; ORwheeze 8.98, 95% CI 4.99 to 16.15, p<0.001).ConclusionsRelative to STARWAVe, GPs underestimated risk of hospitalisation, overprescribed and appeared to misinterpret illness duration (prescribing for longer rather than shorter illnesses). It is important to ascertain discrepancies between CPRs and current clinical practice. This has implications for the integration of CPRs into the electronic health record and the provision of intelligible explanations to decision-makers.

Assessing the risk from emerging infections

2009 ◽  
Vol 137 (11) ◽  
pp. 1521-1530 ◽  
Author(s):  
D. MORGAN ◽  
H. KIRKBRIDE ◽  
K. HEWITT ◽  
B. SAID ◽  
A. L. WALSH
Keyword(s):  
Systematic Approach ◽  
Animal Health ◽  
Good Evidence ◽  
Risk Assessments ◽  
Qualitative Assessment ◽  
Emerging Infections ◽  
Horizon Scanning ◽  
Threat Level ◽  
Potential Impact ◽  
The Uk

SUMMARYEmerging infections pose a constant threat to society and can require a substantial response, thus systems to assess the threat level and inform prioritization of resources are essential. A systematic approach to assessing the risk from emerging infections to public health in the UK has been developed. This qualitative assessment of risk is performed using algorithms to consider the probability of an infection entering the UK population, and its potential impact, and to identify knowledge gaps. The risk assessments are carried out by a multidisciplinary, cross-governmental group of experts working in human and animal health. This approach has been piloted on a range of infectious threats identified by horizon scanning activities. A formal risk assessment of this nature should be considered for any new or emerging infection in humans or animals, unless there is good evidence that the infection is neither a recognized human disease nor a potential zoonosis.

scholarly journals Utilising benefit-risk assessments within clinical trials—a protocol for the BRAINS project

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Nikki Totton ◽  
Steven Julious ◽  
Dyfrig Hughes ◽  
Jonathan Cook ◽  
Katie Biggs ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Trial Design ◽  
Primary Outcome ◽  
Risk Assessments ◽  
Control Treatment ◽  
Guidance Document ◽  
List Type ◽  
Publicly Funded ◽  
Web Based ◽  
The Uk

Abstract Background Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of superiority, equivalence or non-inferiority. The design of the study is affected by many different elements including the control treatment, the primary outcome and associated relationships. In some studies, there could be more than one outcome of interest. In these situations, benefit-risk methodologies could be used to assess the outcomes simultaneously and consider the trade-off between the benefits against the risks of a treatment. Benefit-risk is used within the regulatory industry but seldom included within publicly funded clinical trials within the UK. This project aims to gain an expert consensus on how to select the appropriate trial design (e.g. superiority) and when to consider including benefit-risk methods. Methods The project will consist of four work packages: A web-based survey to elicit current experiences and opinions, A rapid literature review to assess any current recommendations, A two-day consensus workshop to gain agreement on the recommendations, and Production of a guidance document. Discussion The aim of the project is to provide a guideline for clinical researchers, grant funding bodies and reviewers for grant bodies for how to select the most appropriate trial design and when it is appropriate to consider using benefit-risk methods. The focus of the guideline will be on publicly funded trials however, the vision is that the work will be applicable across research settings and we will connect with other organisations and committees as appropriate.

scholarly journals Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project

2020 ◽  
Author(s):  
Nikki Totton ◽  
Steven Julious ◽  
Dyfrig Hughes ◽  
Jonathan Cook ◽  
Katie Biggs ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Trial Design ◽  
Primary Outcome ◽  
Risk Assessments ◽  
Control Treatment ◽  
Guidance Document ◽  
Publicly Funded ◽  
Treatment Benefit ◽  
Web Based ◽  
The Uk

Abstract Background Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of: superiority; equivalence or non-inferiority. The design of the study is affected by many different elements including: the control treatment, the primary outcome and associated relationships. In some studies, there could be more than one outcome of interest. In these situations, benefit-risk methodologies could be used to assess the outcomes simultaneously and consider the trade-off of the benefits against the risks of a treatment. Benefit-risk is used within the regulatory industry but seldom included within publicly funded clinical trials within the UK. This project aims to gain an expert consensus on how to select the appropriate trial design (e.g. superiority) and when to consider including benefit-risk methods. Methods The project will consist of four work packages: 1. A web-based survey to elicit current experiences and opinions, 2. A rapid literature review to assess any current recommendations, 3. A two-day consensus workshop to gain agreement on the recommendations, 4. Production of a guidance document. Discussion The aim of the project is to provide a guideline for clinical researchers, grant funding bodies and reviewers for grant bodies for how to select the most appropriate trial design and when it is appropriate to consider using benefit-risk methods. The focus of the guideline will be on publicly funded trials, however, the vision is the work will be applicable across research settings and we will connect with other organisations and committees as appropriate.

scholarly journals Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project

2021 ◽  
Author(s):  
Nikki Totton ◽  
Steven Julious ◽  
Dyfrig Hughes ◽  
Jonathan Cook ◽  
Katie Biggs ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Trial Design ◽  
Primary Outcome ◽  
Risk Assessments ◽  
Control Treatment ◽  
Guidance Document ◽  
Publicly Funded ◽  
Treatment Benefit ◽  
Web Based ◽  
The Uk

Abstract Background: Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of: superiority; equivalence or non-inferiority. The design of the study is affected by many different elements including: the control treatment, the primary outcome and associated relationships. In some studies, there could be more than one outcome of interest. In these situations, benefit-risk methodologies could be used to assess the outcomes simultaneously and consider the trade-off between the benefits against the risks of a treatment. Benefit-risk is used within the regulatory industry but seldom included within publicly funded clinical trials within the UK. This project aims to gain an expert consensus on how to select the appropriate trial design (e.g. superiority) and when to consider including benefit-risk methods.Methods: The project will consist of four work packages:1. A web-based survey to elicit current experiences and opinions,2. A rapid literature review to assess any current recommendations,3. A two-day consensus workshop to gain agreement on the recommendations,4. Production of a guidance document.Discussion: The aim of the project is to provide a guideline for clinical researchers, grant funding bodies and reviewers for grant bodies for how to select the most appropriate trial design and when it is appropriate to consider using benefit-risk methods. The focus of the guideline will be on publicly funded trials, however, the vision is that the work will be applicable across research settings and we will connect with other organisations and committees as appropriate.

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