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Www.icnarc.org Fungal Infection Risk Evaluation (FIRE) NIHR HTA: 07/29/01 NIHR CRN Portfolio Study ID: 7083 Better targeting of antifungal prophylaxis.

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Presentation on theme: "Www.icnarc.org Fungal Infection Risk Evaluation (FIRE) NIHR HTA: 07/29/01 NIHR CRN Portfolio Study ID: 7083 Better targeting of antifungal prophylaxis."— Presentation transcript:

1 www.icnarc.org Fungal Infection Risk Evaluation (FIRE) NIHR HTA: 07/29/01 NIHR CRN Portfolio Study ID: 7083 Better targeting of antifungal prophylaxis to improve care and outcomes…

2 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 Scope - FIRE Study Call to research grant

3 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

4 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 Scope - FIRE Study Call to research grant Aim/objectives/phases

5 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

6 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

7 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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)

8 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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)

9 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 Scope - FIRE Study Call to research grant Aim/objectives/phases Infrastructure

10 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 Investigators Role: design and conduct of FIREStudy Chief Investigator – Dr David Harrison Senior statistician, ICNARC Co-investigators – Dr Rosemary BarnesMicrobiologist – Dr Jonathan EdgeworthMicrobiologist – Dr Richard GrieveHealth economist – Dr Mark JitHealth economist – Prof Christopher KibblerMicrobiologist – Prof Kathy RowanDirector, ICNARC – Dr Neil SoniCritical care

11 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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 StambachCritical care And… – Dr Gav EyresStudy Coordinator – Research FellowTo be appointed

12 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

13 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 Scope - FIRE Study Call to research grant Aim/objectives/phases Infrastructure Preparation

14 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

15 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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)

16 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 Scope - FIRE Study Call to research grant Aim/objectives/phases Infrastructure Preparation Literature review to inform dataset

17 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

18 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 Scope - FIRE Study Call to research grant Aim/objectives/phases Infrastructure Preparation Literature review to inform dataset Dataset/data collection

19 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 FIRE dataset Dataset defined in five sections: Patient details Pre-admission First 24 hours By end of calendar day 3 Outcomes

20 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

21 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

22 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

23 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 FIRE dataset – Outcomes – Fungal colonisation – Invasive fungal disease – Use of systemic antifungal drugs – Use of topical antifungal drugs – Surgery (first during unit stay)

24 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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)

25 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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!

26 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009

27 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 Scope - FIRE Study Call to research grant Aim/objectives/phases Infrastructure Preparation Literature review to inform dataset Dataset/data collection Why take part?

28 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

29 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

30 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

31 www.icnarc.org FIRE (NIHR HTA: 07/29/01)| © ICNARC September 2009 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

32 www.icnarc.org Fungal Infection Risk Evaluation (FIRE) For further information about FIRE email: fire@icnarc.org Better targeting of antifungal prophylaxis to improve care and outcomes…


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