Where to in Scotland for Critical Care Research''a research network

1
Where to in Scotland for Critical Care
Research..a research network?

• Tim Walsh
• Chair NIHR CCRN Critical Care Specialty Group
• Chair, SCCTG Executive Group

2
The Operating Framework for the NHS in England
2009/10

• 18. NHS trusts and NHS foundation trusts have
  a statutory duty to support education and
  training. All providers of NHS care will need to
  increase their participation in research. The
  national ambition is to double the number of
  patients taking part in clinical trials and other
  well-designed research studies within five years.
  SHAs are expected to ensure that NHS trusts work
  with the National Institute for Health Research
  Comprehensive Clinical Research Network locally
  to contribute to this progressive increase.

3
UK Clinical Research Network

• UKCRN
• Launched in February 2005 as part of UKCRCs
  research infrastructure workstream
• Coordinating centre in Leeds and London
• National Cancer Research Network (NCRN) already
  in existence - established in 2001
• Mental Health Research Network (MHRN) already in
  existence established 2004
• Another four TCRNs created from scratch

4
NIHR CLRN Funding

• Stage 1 2007 - 2008
• Establishing the NIHR CLRNs
• Fixed allocation to support the management team
• Per capita of population served allocation for
  research management staff
• Per capita of population served allocation for
  research infrastructure

5
NIHR CLRN Funding

• Stage 2 2008 - 2009
• All CLRNs continue to receive the fixed and per
  capita allocations as in 2007/08
• In addition each CLRN will also receive
  activity-based funding - a flexible allocation
  calculated on the basis of past activity for that
  CLRN
• Activity-based funding recalculated annually
• Funding follows activity!

6
(No Transcript)
7
Specialty Groups

• Groups based on the UKCRC Health Research
  Classification System
• Provide expertise to the UKCRN and NIHR CCRN in
  twenty-six specific topics not covered by the
  TCRNs
• Secretariat provided by the UKCRN Coordinating
  Centre Coordinator and Clerical Officer

8
Specialty Group Remit

• Portfolio Development vs Portfolio Delivery
• Specialty Groups funded to improve portfolio
  delivery rather than to drive portfolio of
  research in a specific topic area
• BUT potential to interact with portfolio
  development groups
• Eg ICNARC, ICS, UK Trial forum etc

9
Prof Tim Walsh (Chair) Dr Jonathan Benger (Vice
Chair) Dr Stephen Bonner Dr Jonathan Coles Prof
Charles Hinds Dr Danny McAuley Dr Jonathan
Thompson Dr Duncan Young Prof Julian Bion Prof
Timothy Evans Prof Richard Griffiths Dr Suzanne
Mason Dr David Higgins Dr Mike Grocott Dr Gavin
Perkins Co-opted Kathy Rowan (ICNARC) Fiona
Lecky (TARN) 13 of 26 CLRNs 2 of 3 devolved
nations
10
Eligibility for NIHR portfolio

• Basic requirements funded in open national
  competition and with independent peer review
• Automatic NIHR partners e.g. MRC, DH, major
  charities
• High priority with adoption process industry
  sponsored studies
• Medium priority with adoption process e.g. EU
  or internationally funded studies, industry
  collaborative studies

11
Non-automatic funders

• Review by adoption panel process
• Review by experts in field (from specialty
  groups) for
• Suitability/Practicalities
• Relevance
• In context of current portfolio
• Applies to commercial and non-commercial
  non-automatic studies
• (No commercial studies yet on the critical
  care/EM portfolio)

12
Eligibility of funders

• Grey areas still exist
• Funding bodies have to register for eligibility
• Intensive Care Society, NIAA and other relevant
  funders still awaiting decisions

13
Portfolio

• Studies covering critical care and emergency
  medicine (mainly)
• Observational and interventional studies
• Single centre and multicentre studies
• CLRNs that have nominated critical care as a
  local priority should support portfolio studies
• Nature of support not clearly defined
• Accrual to these studies generates resource to
  local CLRN

14
Overview of studies

• 23 active on the portfolio
• 2 studies registered on the portfolio, but in set
  up
• 4 studies in set up, not yet on portfolio
• 2 studies completed/closed
• TracMan (909 patients reported to
  investigators/Brussels)
• SIGNET (502 patients reporting to investigators
  October/ESICM Vienna)

15
Total studies 23
Multicentre studies 17
Single centre studies 6
Emergency Medicine 7
Critical Care 10
Critical Care 6
16
Total studies 23
Multicentre studies 17
Single centre studies 6
Emergency Medicine 7
Critical Care 10
Critical Care 6
Observational or non-intervention 3 RCT 4
Observational or non-intervention 2 RCT 8
Observational or non-intervention 5 RCT 1
17
Total studies 23
Multicentre studies 17
Single centre studies 6
Emergency Medicine 7
Critical Care 10
Critical Care 6
Observational or non-intervention 3 RCT 4
Observational or non-intervention 2 RCT 8
Observational or non-intervention 5 RCT 1
18
RCTs in Critical Care

• High frequency oscillatory ventilation versus
  conventional ventilation for ARDS (OSCAR)
• The Beta 2 agonist lung injury trial (BALTI II)
• The utility of cardiopulmonary exercise testing
  for pre-operative risk stratification to guide
  perioperative care and reduce postoperative
  morbidity
• Beta agonist lung injury prevention trial
  (BALTI-prevent)
• Impact of an aerobic exercise rehabilitation
  programme on fitness and QOL in ICU survivors

19
RCTs in Critical Care

• A feasibility randomised trial comparing
  restrictive versus liberal blood transfusion
  strategies in patients requiring four or more
  days of mechanical ventilation (RELIEVE)
• Randomised evaluation of surgery with craniectomy
  for uncontrollable elevation of intracranial
  pressure
• Optimisation of perioperative cardiovascular
  management to improve surgical outcomes (OPTIMISE)

20

• The Beta 2 agonist lung injury trial (BALTI II)
• Fang.Gao_at_warwick.ac.uk

21
BALTI II

• A multicentre pragmatic randomised double-blind
  placebo-controlled
• clinical trial
• Patients fulfilling the American-European
  Consensus Conference Definition
• of ARDS
• Randomised 11 to receive an IV infusion either
  of salbutamol
• or placebo for a maximum of seven days
• Data recorded by participating ICUs until
  hospital discharge and all
• surviving patients followed up by post at six
  and twelve months
• post randomisation
• Primary outcome is mortality at 28 days after
  randomisation
• Secondary outcomes are a range of mortality,
  ventilation, QOL,
• and economic outcomes
• 1,334 patients from about fifty ICUs in the UK

22

• Beta agonist lung injury prevention trial
  (BALTI-prevent)
• gavin.perkins_at_virgin.net

23
BALTI-prevent

• Double blind RCT
• Patients undergoing oesophagectomy
• Inhaled salmeterol versus placebo during
  perioperative period
• Follow up for 3 months
• 216 patients
• Primary outcome reduction in acute lung injury

24
OSCAR

• multicentre, randomised controlled trial (RCT)
  comparing conventional positive pressure
  ventilation with high frequency oscillatory
  ventilation (HFOV) for adults with acute
  respiratory distress syndrome (ARDS).
• Treatment A Conventional positive pressure
  ventilation, or Treatment B High frequency
  oscillatory ventilation. 
• The primary outcome is mortality at 30 days after
  randomisation
• Secondary outcomes at 6, 12 months (include QOL,
  functional measures)
• 1006 patients in 12 centres

25
Total studies 23
Multicentre studies 17
Single centre studies 6
Emergency Medicine 7
Critical Care 10
Critical Care 6
Observational or non-intervention 3 RCT 4
Observational or non-intervention 2 RCT 8
Observational or non-intervention 5 RCT 1
26
Non-interventional/observational studies

• Genetic and epigenetic modulators of gene
  expression in sepsis as part of the UK Genomic
  Advances in Sepsis (GAinS) study
• Charles Hinds/Julian Knight
• A study of the long term economic impact of
  critical illness and its association with health
  related QoL in patients discharged from Intensive
  Care Units (iCAN-UK)
• Steve Brett/John Griffiths

27
Other Pipeline Projects

• Risk Adjustment in Neuro Critical Care (RAIN)
• RCT of early enteral with parenteral nutrition
  (CALORIES)
• RCT of Early Goal Directed Therapy for Sepsis
  (PROMISE)
• RCT of Therapeutic hypothermia in head injured
  patients (EUROTHERM)

28
Scotland

• Funding structure fundamentally different
• RD departments
• Currently undergoing period of disembedding
  funding
• Academic Health Science Centres
• No Accrual funding/payments for portfolio studies
• Network funding for Critical Care not committed
• Scotland considered a single entity in UK process

29
Scottish Solutions

• Approach to the CSO
• Building up momentum through individual Board RD
  support (research nurses and coordinators)
• Professional collaboration nationally
• Changing role for the SCCTG
• Recording National Accrual as a
  quality/performance marker through the SCCTG/SICS

30
Any Ideas?