Health Protection and Influenza Research
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FLU-CATs study

Aim

The aim of this study is the real time refinement and validation of criteria and tools used in primary care to aid hospital referral decisions for patients of all ages in the event of surge during an influenza pandemic.

This study will develop processes that will test how parts of a general practitioner's questions and assessment of children and adults with flu like illness can predict who: can safely be kept at home; need hospital admission; need high dependency or intensive care; are most at-risk of dying.

The FLU-CATs study has been funded under an NIHR Pandemic themed research call.

Dr Calum Semple, FLU-CATs Principle Investigator, talks about the study.

 

Study background

Flu pandemics occur when a new flu virus emerges, rapidly spreads and causes widespread disease in many communities in many continents.

Fortunately severe pandemics are rare events. When they occur, health care capacity both in the community and hospitals can be overwhelmed. When this happens doctors need to make difficult decisions about who should be admitted to hospital and who can safely be allowed to stay at home.

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To do this fairly, most doctors feel that the same types of patient assessments and questions should be used across the wider community. This process is called triage. Triage tools should help doctors identify which people are most likely to benefit from treatments only available in hospital and which people can safely be managed at home.

The difficulty in designing triage tools for a future flu pandemic is that the exact nature of disease caused by a pandemic virus is generally unknown until that pandemic occurs. A further difficulty is that flu can affect children and adults quite differently. A one-size-fits-all tool is unlikely to work.

The study uses the GP's routine electronic record to capture most of the information and links to the hospital record if the patient is admitted to hospital. These records are be accessed by researchers without revealing people’s identities at the Clinical Practice Research Datalink, which is part of the Medicines and Healthcare products Regulatory Authority (MHRA).

The surgeries that participate already have long established permission to use anonymous clinical data for non-intervention studies [The General Practice Research Database: provision of anonymised data for use in observational public health].

 

Frequently asked questions

What’s this study really about?

The use of triage tools during surge and mass casualty events is recommended in national guidance. The need for such tools was identified again in preparation for the recent Olympic and Paralympic Games.

The evidence base for this guidance was challenged by GPs at the RCGP Pandemic Flu Summit in March 2010. GPs questioned the extent to which they as a group had been involved in the development of the tools. GPs were also concerned that there is little data supporting use of such tools in primary care.

This study aims, with your help, to develop and test these triage tools to be used in case of a pandemic. The data as collected as part of this study will be combined anonymously by the research team with data from hospital admissions in order to test the validity of the triage tool.

 
What does it involve for us as GPs?

A study pop-up box will appear when an eligible patient is identified during consultation. This is triggered by your entry of a relevant Read code in the patient’s electronic health record. There is no need for formal enrolment of patients.

You will be asked to record your routine assessment and decisions in a structured way using radio buttons and drop-down lists. This is very quick.

We recognise your clinical time is precious, so to avoid any double-entry of data, a summary of your entry will be presented in a friendly format ready to be cut-and-pasted back into the patient’s record. A downloadable pdf containing the same information will also be offered.

 

How can I participate in the study

If you are a GP working in a practice that contributes data to CPRD and would like to participate in the FLU-CATs study, please contact Dr Malcolm (Calum) Semple at m.g.semple@liverpool.ac.uk.

 

Can I test it out before I commit to the study?

Yes, you can try the entry screens on our live test site without commitment, using the links below:

 

What about ethics, R&D approval and consent?

The protocol has been reviewed by the NIHR, the PCRN and the Independent Scientific Advisory Committee for MHRA database research. 

The information required for this study is collected as part of routine clinical care in an anonymous format.

The study is registered with the UK Clinical Research Network; see details of registration, permissions and the full protocol .

 

 

 

Meet the team

Calum Semple
Dr Malcolm (Calum) Semple
Senior Lecturer in Child Health at the University of Liverpool; Consultant in Paediatric Respiratory Medicine at Alder Hey Children’s Hospital.
 

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His research interests include investigating the clinical and immunological factors associated with severe respiratory viral infections caused by human respiratory syncytial virus, human metapenumovirus and influenza virus.

In 2008 Dr Semple was seconded to the Department of Health Pandemic Influenza Programme joining Dr Barbara Bannister as a clinical advisor. Between them they supported the development of clinical guidance, community triage tools and hospital pathways in preparation for a future pandemic. At the onset of the 2009 A(H1N1) pandemic he joined the Cabinet Office Pandemic Influenza Clinical Operational Group as an independent expert advisor and with Professor Jonathan van Tam established the UK Pandemic Influenza Clinical Information Network (FLU-CIN).

He provides a weekly paediatric respiratory outpatient clinic and bronchoscopy service with colleagues at Alder Hey Children’s Hospital. Calum was a volunteer at the London 2012 Summer Olympic Games and lead the field of play medical team at the shooting events held at the Royal Artillery Barracks Woolwich.

http://www.liv.ac.uk/info/staff/A313622

Dr Puja Myles
Associate Professor of Health Protection and Epidemiology at the University of Nottingham
 

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Dr Myles’s main area of interest is infectious disease epidemiology. Her current research area is influenza, in particular pandemic influenza. She is providing the methodological lead for the FLU-CATs study.

See Dr Myles's University profile

Professor Jonathan Van-Tam
Professor of Health Protection at the University of Nottingham
 

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Professor Jonathan Van-Tam heads the Health Protection and Influenza Research Group at the University of Nottingham.

Prof. Van-Tam is a widely recognised national and international expert on influenza and advises multiple governments, the WHO and European Centre for Disease Prevention and Control. He has an advisory role on the FLU-CATs study.

See Professor Van Tam's University profile

JamieKirkham
Dr Jamie Kirkham
Lecturer in Medical Statistics at the University of Liverpool
 

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Jamie Kirkham qualified with a PhD in Medical Statistics (2006) at Lancaster University. He worked as a Research Associate (2006 to 2010) in the Department of Biostatistics at the University of Liverpool, working on two research projects; ‘Outcome Reporting Bias in Trials’ and ‘Adverse Drug Reactions in Children’. He is now a Lecturer in Medical Statistics at the University of Liverpool.

Jamie specialises in the application and development of statistical methods for evidence synthesis and meta-analysis with particular emphasis on bias reduction techniques. A particular research passion is to improve the quality, design, conduct, analysis and reporting of research studies. He has an advisory role on the FLU-CATs study.

SudhirVenkatesan
Dr Sudhir Venkatesan
Research Assistant, Division of Epidemiology and Public Health, University of Nottingham

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Dr Sudhir Venkatesan obtained a Master’s degree in Public Health from the University of Nottingham in 2011. He has since been working in the Division of Epidemiology and Public Health as a Research Assistant. He is involved in the management and analysis of data from the FLU-CATs study.
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Dr Tim Williams 
Head of Research, CPRD

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Dr Tim Williams is a Head of Research within the newly formed Clinical Practice Research Datalink (CPRD) within the Medicines and Healthcare products Regulatory Agency (MHRA). He has an MSc in Epidemiology from London School of Hygiene and Tropical Medicine and PhD in biomedical computing from the University of Leeds. He has worked in the healthcare data field for over 18 years both in academia and within government. As the programme manager for the research group he has oversight of a wide range of projects but his main area of research involves work into observational healthcare data quality and the application of large observational databases to novel areas including RCT feasibility. He holds an honorary research fellowship at the Brighton and Sussex Medical School, and collaborates on a small number of other funded academic research projects.
gerardmccann 
Gerard McCann 
Clinical Trials Operations Manager, CPRD

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Gerard McCann has worked at CPRD (and previously GPRD) since January 2007. His first role as Data Quality Team Manager included delivery of many large-scale verification studies. Following his appointment as Clinical Trials Manager in 2010 he has successfully designed, managed and delivered a broad range of complex clinical projects including pragmatic trials, cluster randomised trials and biosample studies. Gerard’s current role is Clinical Trials Operations Manager. His role in the FLU-CATs study is to co-ordinate activities across CPRD’s operations, technical and research teams, ensuring that study targets are met.
shivanipadmanabhan 
Shivani Padmanabhan
Senior Research Programmer, CPRD

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Shivani Padmanabhan obtained a BEng in Computer Science from the University of York in 2003, and obtained an MSc in Informatics with a specialisation in Bioinformatics in 2004 from the University of Edinburgh. Shivani has worked at CPRD (and previously GPRD) since March 2007. Her primary expertise is in programming, software development, and systems delivery. She currently works on CPRD data systems towards the development and management of current and new data streams in CPRD, and successfully designed, developed, and deployed the data processing system for running pragmatic trials. Shivani’s current role is Senior Research Programmer. Her role in the FLU-CATs study is to provide technical input.
rabahbelatri
Rabah Belatri
Technical Analyst, CPRD

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Rabah Belatri has an HND in Computing and a BSc Hons degree in Information Systems from The University of East London. He has worked in various academic organisations such as the London School of Hygiene and Tropical Medicine, before joining CPRD as a web and application developer.
He has since taken part in all technical aspects of the various clinical studies at CPRD, including a major role in the website development and interface applications for two recent Randomised Controlled Trials. He currently manages the FLU-CATs study website and systems.
maimoonahashmi
Maimoona Hashmi
Clinical Trials Support Administrator, CPRD

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Maimoona Hashmi joined CPRD’s Data Quality Team in 2013 as Clinical Trials Support Administrator. She provides logistical and administrative support for clinical trials and qualitative studies. A significant part of her role is to deliver verification (GP questionnaire) studies. Her role in FLU-CATs has been to recruit practices and GPs, work with them to ensure study effectiveness and document study activities. Maimoona also provides support to practices in the deployment of the patient flagging software and questionnaire completion activities.
emmaboyle 
Emma Boyle
Data Services Team Manager, CPRD

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Emma Boyle has worked at CPRD (and previously GPRD) since July 2011. Her role as Data Services Team Manager has included delivery of many large scale verification studies, free text and bio-sample studies. Her role in the FLU-CATs study is to assist with recruitment of general practices to the study, with the installation of LEPIS software to participating practices, and to provide support to practice staff.
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Dr Antonis Kousoulis
Academic Research Liaison, CPRD

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Dr Antonis Kousoulis is a physician with a background in epidemiology and humanities. He has completed studies in the University of Athens, Greece, and Imperial College London. He currently serves as the Academic Research Liaison at CPRD and Business Development Lead for Clinical Trials within MHRA, in the UK Department of Health. He has participated in research protocols in the Clinic of Social Medicine at University of Crete, Greece, the Science and Technology Department at University College London, and the Center for Global Tobacco Control at Harvard School of Public Health. He is also a fellow of the London School of Hygiene and Tropical Medicine where he gets involved in the Public Confidence in Vaccines group.

 

 

 

FLU-CATs demonstration

A demonstration on how easy it is to use the community assessment tool. 

 

 

Health Protection and Influenza Research

Division of Epidemiology and Public Health
Nottingham City Hospital
The University of Nottingham
Hucknall Road, Nottingham, NG5 1PB


telephone: +44 (0)115 823 0276
email:Jonathan.Van-Tam@nottingham.ac.uk