Fungal Infection Risk Evaluation FIRE

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Fungal Infection Risk Evaluation (FIRE)
Better targeting of antifungal prophylaxis to
improve care and outcomes

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

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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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Objectives (ii)

• 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

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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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Investigators

• Role 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 Group

• Role 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 Group

• Role 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)
• RD main application
• England, Wales and Northern Ireland (July 2009)
• Site specific RD 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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Scope - FIRE Study

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

• Call to research grant
• Aim/objectives/phases
• Infrastructure
• Preparation
• 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
• 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)
Better targeting of antifungal prophylaxis to
improve care and outcomes

• For further information about FIRE email
  fire_at_icnarc.org