Better targeting of antifungal prophylaxis to improve … Overview Slides v1.2 February... · Better targeting of antifungal prophylaxis ... – Use of systemic antifungal drugs

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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, FIRE Overview, July 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 Kibbler Microbiologist– 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 Critical care– Dr Thomas Stambach Critical care

• And…– Ms Hannah Barnes Study Coordinator– Research Fellow To be appointed

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Study Management GroupRole: day-to-day running of FIRE Study• David Harrison (Chief Investigator)• Hannah Barnes (Study Coordinator)• Phil Restarick (Research Coordinator)• Kathy Rowan (Co-investigator)• Emma Walmsley (Research Administrator)

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:

– Research Coordinator (Phil Restarick)• April 2009

– New Study Coordinator (Hannah Barnes)• January 2010

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FIRE (NIHR HTA: 07/29/01)• Ethics approval (March 2009)

– England, Wales and Northern Ireland (09/MRE09/10)

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

• R&D main application (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• Local funding – CLRN

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Comprehensive Local Research Network (CLRN) funding• England has been divided into 25 regions,

each of these is a CLRN (see next slide)• Each CLRN receives a budget to manage

and deliver research for its region• Many CLRNs have critical care leads (see

next slide)• FIRE is a NIHR CRN Portfolio study so units

taking part in the study in England are eligible to apply for funding for NHS support costs through their CLRN

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Comprehensive Local Research Network (CLRN) funding

• Even if there is no critical care lead in your CLRN, you can still apply for funding

• FIRE fully adopted onto NIHR CRN Portfolio (NIHR CRN Study ID: 7083)

• For further information on CLRN funding: www.ukcrn.org.uk

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

– CMP admission number– NHS 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/Neutropenic/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 (at any time 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 your unit• FIRE (and CMP…) 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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Scope - FIRE Study• Call to research grant• Aim/objectives/phases• Infrastructure• Preparation• Local funding – CLRN• Literature review to inform 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• Local funding – CLRN• 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 Trust• 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• Local funding – CLRN• 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…

Documents

Better targeting of antifungal prophylaxis to improve … Overview Slides v1.2 February... · Better targeting of antifungal prophylaxis ... – Use of systemic antifungal drugs