www.icnarc.org fungal infection risk evaluation (fire) nihr hta: 07/29/01 nihr crn portfolio study...

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Fungal Infection Risk Evaluation (FIRE)

NIHR HTA: 07/29/01NIHR CRN Portfolio Study ID: 7083

Better targeting of antifungal prophylaxis to improve care and outcomes…

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FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009

Scope - FIRE Study• Call to research grant

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Fungal Infection Risk Evaluation• HTA call

- Outline proposal (April 2007)- Full proposal (September 2007)- Response to reviewers (January

2008)- Final full proposal (April 2008)- Contract signed (September 2008)

• National Institute for Health Research (NIHR) HTA grant number : 07/29/01

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Scope - FIRE Study• Call to research grant• Aim/objectives/phases

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Aim

To develop and validate a risk model to identify critically-ill adult patients at high risk of invasive fungal disease, to be used to identify which patients would most benefit from antifungal prophylaxis

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Objectives (i)

• To identify potential factors associated with increased risk of invasive fungal disease (IFD)

• To collect data on risk factors/IFDs for consecutive admissions to adult, general, critical care units

• To develop and validate a risk model to identify critically-ill, adult patients at high risk of IFD

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• Using estimates, both from previous randomised controlled trials (RCTs) and from the risk model, to model the clinical and cost-effectiveness of using antifungal prophylaxis in critically-ill, adult patients identified as being at high risk of IFD

• To make recommendations for further research and to establish the optimum strategy for use of antifungal prophylaxis in critically-ill, adult patients

Objectives (ii)

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FIRE Study phases

• Study preparation– Nov 2008 to June 2009 (eight months)

• Collect/validate data– July 2009 to December 2010 (eighteen months)

• Recruit statistical modeller Develop/validate models

– May 2010 to Feb 2011 (ten months)

• Cost-effectiveness analysis – May 2010 to March 2011 (eleven months)

• Report writing and dissemination– August 2010 to April 2011 (nine months)

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Scope - FIRE Study• Call to research grant• Aim/objectives/phases• Infrastructure

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InvestigatorsRole: design and conduct of FIRE Study

• Chief Investigator – Dr David Harrison Senior

statistician, ICNARC

• Co-investigators– Dr Rosemary Barnes

Microbiologist– Dr Jonathan Edgeworth Microbiologist– Dr Richard Grieve Health economist– Dr Mark Jit Health economist– Prof Christopher KibblerMicrobiologist– Prof Kathy Rowan Director, ICNARC– Dr Neil Soni Critical care

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Study Steering GroupRole: overall supervision of FIRE Study on

behalf of the funder (HTA) and sponsor (ICNARC)

• Investigators plus independent members– Dr Bernard Riley (Chair) Critical care– Dr Ronan McMullan Microbiologist– Dr Thomas Stambach Critical care

• And…– Dr Gav Eyres Study Coordinator– Research Fellow To be appointed

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Study Management GroupRole: day-to-day running of FIRE Study

• Andrew Craven (Research Administrator)• David Harrison (Chief Investigator)• Gav Eyres (Study Coordinator)• Phil Restarick (Research Coordinator)• Kathy Rowan (Co-investigator)

All based at ICNARC

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Scope - FIRE Study• Call to research grant• Aim/objectives/phases• Infrastructure• Preparation

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FIRE (NIHR HTA: 07/29/01)• Appointments:

– Study Coordinator (Gav Eyres)• October 2008

– Study Administrator (Andrew Craven)• February 2009

– Research Coordinator (Phil Restarick)• April 2009

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FIRE (NIHR HTA: 07/29/01)• Ethics approval

– England, Wales and Northern Ireland (March 2009)

(09/MRE09/10)– Scottish application submitted

• National Information Governance Board for Health and Social Care (NIGB) (Sept 2008)

• R&D main application – England, Wales and Northern Ireland (July 2009)

• Site specific R&D approvals (ongoing)

• Portfolio adoption (July 2009)

• Final recruitment of units (ongoing)

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Scope - FIRE Study• Call to research grant• Aim/objectives/phases• Infrastructure• Preparation• Literature review to inform

dataset

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Systematic literature review

• Resulted in over 2000 paper titles- Over 200 selected for review of abstract- Over 70 selected for review of full paper

• Risk factors were abstracted from relevant papers

• Risk factors were defined and comprehensive dataset specification developed

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dataset• Dataset/data collection

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FIRE dataset

Dataset defined in five sections:• Patient details• Pre-admission• First 24 hours• By end of calendar day 3• Outcomes

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FIRE dataset – Patient details• To allow linkage between FIRE &

CMP/SICSAG– CMP/SICSAG admission number– NHS number/CHI number– Hospital number– Date of birth– Sex– Date of admission to your hospital– Date of admission to your unit– Time of admission to your unit

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FIRE dataset – Pre-admission

• Condition/classification/complications of surgery

• Number or presence of:– Lines/Devices/Catheters/Drains/Feeding

tubes

• Receipt of:– Organ support (respiratory/renal)– TPN/Steroids/Immunosuppressives/

Antimicrobials

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FIRE dataset – First 24 hours/By end of calendar day 3

• Number or presence of:– Lines/Devices/Catheters/Drains/Feeding

tubes

• Receipt of:– Organ support (respiratory/renal)– TPN/Steroids/Immunosuppressives/

Antimicrobials

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FIRE dataset – Outcomes– Fungal colonisation– Invasive fungal disease– Use of systemic antifungal drugs– Use of topical antifungal drugs– Surgery (first during unit stay)

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Data collection• Recruiting approx. 80 units

– 40,000 admissions – (12 months data collection to develop

model)– 20,000 admissions – (6 months data collection to validate

model)• Consecutive admissions to unit• FIRE (and CMP/SICSAG…) dataset collected• FIRE Data Collection Form available• FIRE data entered onto secure web-based data

entry system via ICNARC website (www.icnarc.org)

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Secure web-based data entry system• Register on ICNARC website

(user access granted by ICNARC administrator - usually within 24 hours)

• Login on ICNARC “Homepage”(login details in top right corner)

• For users registered as participating in FIRE –“Data Entry” tab will appear on navigation bar

• Click on “Data Entry” tab • Click on the FIRE Study logo• Click on your hospital name to enter/edit data• Enter data for consecutive admissions!

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dataset• Dataset/data collection• Why take part?

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Why take part?

• Contribute to better targeting of antifungal prophylaxis to improve care and outcomes

• Gain insight into your invasive fungal disease rates and have national comparative data

• Improve care and outcomes for critical care patients in your unit

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Scope - FIRE Study• Call to research grant• Aim/objectives/phases• Infrastructure• Preparation• Literature review to inform dataset• Dataset/data collection• Why take part?• How to take part

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How to take part• Identify a Local Collaborator (LC) who will be

responsible for the Study locally • Fill out the site-specific information for your

Health Board• Attend a FIRE Dataset Familiarisation Course • LC responsible for:

– ensuring access is available to the secure, web-based data entry system

– ensuring accurate and timely data collection and entry onto the secure, web-based system, for consecutive admissions

• Sign Research Agreement to indicate acceptance of LC responsibilities

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Scope - FIRE Study• Call to research grant• Aim/objectives/phases• Infrastructure• Preparation• Literature review to inform dataset• Dataset/data collection• Why take part?• How to take part• Contact details

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Fungal Infection Risk Evaluation (FIRE)

For further information about FIRE email: [email protected]

Better targeting of antifungal prophylaxis to improve care and outcomes…

www.icnarc.org fungal infection risk evaluation (fire) nihr hta: 07/29/01 nihr crn portfolio study...

Documents

funder hta

risk model

high risk of ifd slide

research grant slide

antifungal prophylaxis

sponsor icnarc investigators

risk factorsifds

nihr crn portfolio study