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Caroline Watkins
Professor of Stroke & Older People’s Care
Director of Research and Innovation, College of Health and Wellbeing
University of Central Lancashire
Preston, UK
&
Australian Catholic University, Sydney
clwatkins@uclan.ac.uk
Participation in Health Research:
Edge walking?
Research priorities those of clinicians?
“Practitioners will continue to ignore research
publications until they are seen as helpful and
relevant”
Sobell (1996)
Key Message
Today’s research is tomorrow’s care……
Trainees Coordinating CentreTrainees Coordinating Centre
National Institute for Health Research
Established 2006:
A vehicle for implementing
Government’s strategy for
applied health research
£1bn annual spend
Vision:
Improving health and wealth
of nation through research
15
Trainees Coordinating CentreTrainees Coordinating Centre
NIHR Remit
• People and patient based applied health research
• Research capacity to improve health/healthcare
• Patients, samples or data from patients, people who are
not patients, populations, health technology assessment
and health services research
• The potential to have an impact on the needs of patients
and the public within 5 years of completion
• Prepared to support research into medical education
• No basic research involving animals and/or animal tissue
Trainees Coordinating Centre
Research Training
Opportunities from
NIHR
David Richards, PenCLAHRC,
University of Exeter Medical School
(additional material from Peter Thompson, NIHR TCC)
Really? Me?
Trainees Coordinating CentreTrainees Coordinating Centre
Trainees Coordinating CentreTrainees Coordinating Centre
NIHR Fellowships Programme
• Salary
• Full tuition fees (for PhD)
• Research costs
• Full training and development
• Awards 3 years full time (part-time options of 75% or
60%) or up to 5 years for SRF
• Can be based at HEI or NHS Trust
• Annual competition for all levels
• Next launch – October 2016
Trainees Coordinating CentreTrainees Coordinating Centre
Post Doctoral Research
Fellowship (NIHR PDF)
Early post doctoral Fellowship
(≤ 3 years WTE Post Doctorate)
3 years FT (4 or 5 years PT)
Applicant:
PhD/MD or have submitted
Output from research
Evidence of commitment to
research career
Doctoral training award
3 years FT (4 or 5 years PT)
Applicant:
Some previous research experience
Some outputs from research
Evidence of commitment to research
career
Doctoral Research Fellowship
(NIHR DRF)
NIHR Fellowships
Trainees Coordinating CentreTrainees Coordinating Centre
Senior Research Fellowship
(NIHR SRF)
Most senior NIHR Fellowship
5 years ( Chair)
Applicant:
Significant postdoctoral experience
Outstanding publication record
Independence
Leadership potential
Record of research capacity
development
Later postdoctoral award (≤ 7 yrs
WTE Post Doctorate)
3 years FT (4 or 5 years PT)
Applicant:
PhD/MD and postdoctoral
experience
Significant output from research
Evidence of increasing
independence
Experience of developing research
skills of others
Career Development Fellowship
(NIHR CDF)
NIHR Fellowships
Trainees Coordinating CentreTrainees Coordinating Centre
NIHR Fellowships
Postdoctoral award (≤ 5 yrs WTE Post Doctorate)
18 months to 2 years FT or PT
Applicant:
PhD/MD and maybe postdoctoral experience
• Individuals from any scientific discipline wanting to
contribute to improving health or healthcare e.g. basic
scientists moving to applied health research
• Individuals who have had their research careers
interrupted e.g. career break, who can identify clear
training needs
• Proposed research must be within the NIHR remit
Transitional Research Fellowship
(NIHR TRF) new from 2013
Trainees Coordinating CentreTrainees Coordinating Centre
HEE/NIHR Integrated Clinical
Academic Programme
Health Education England Review recommended expansion to all
registered non medical/dental registered healthcare professionals
committed to developing a career which combines research and
continued clinical practice.
Trainees Coordinating CentreTrainees Coordinating Centre
Trainees Coordinating CentreTrainees Coordinating Centre
HEE/NIHR Integrated Clinical
Academic Programme
• Funded HEIs advertise places
(institutional award)
• 100 places per annum
available over next 3 years
• The University of Manchester
• University of Nottingham
• University of Leeds
• The City University London
• University of Southampton
• University of Brighton
• Kingston University London
• University of Plymouth
• University of East Anglia
• Coventry University
• PhD research whilst developing clinical skills
• Based at English NHS trust, other health care
organisation or HEI
• Min 1 yr clinical experience and current statutory
registration
• Need for both a good academic and clinical
supervisor
• Salary, PhD tuition fees, research, training &
development costs (100% NHS, 80% HEI except
training & development @100%)
• 3 years FT (4 or 5 years PT)
• Next call March 2017
HEE/NIHR Masters in
Clinical Research
HEE/NIHR Clinical Doctoral Research
Fellowship
Trainees Coordinating Centre
Good Applications
1. Applicant
• (trajectory, career outputs)
2. Research Project
• (scientific quality, appropriate scale and scope)
3. Training and Development
• (meet the needs of the candidate and the project)
4. Environment
• (research Excellence Framework rating, facilities)
5. Supervision/mentorship
• (track record in relevant field, time and commitment)
Trainees Coordinating Centre
Project
• Doable
• Applied
• Relevant
• Five year impact rule
• Quality high
• PPI
– VETO ALERT!
– Do not confuse PPI with focus groups and qualitative data –
that’s different (so don’t include that piece in the PPI section).
PPI is actual involvement in the research process itself.
– PPI is NOT people as research participants/subjects giving data
Trainees Coordinating CentreTrainees Coordinating Centre
HEE/NIHR Integrated Clinical
Academic Programme
• Funded HEIs advertise places
(institutional award)
• 100 places per annum
available over next 3 years
• The University of Manchester
• University of Nottingham
• University of Leeds
• The City University London
• University of Southampton
• University of Brighton
• Kingston University London
• University of Plymouth
• University of East Anglia
• Coventry University
• PhD research whilst developing clinical skills
• Based at English NHS trust, other health care
organisation or HEI
• Min 1 yr clinical experience and current statutory
registration
• Need for both a good academic and clinical
supervisor
• Salary, PhD tuition fees, research, training &
development costs (100% NHS, 80% HEI except
training & development @100%)
• 3 years FT (4 or 5 years PT)
• Next call March 2017
HEE/NIHR Masters in
Clinical Research
HEE/NIHR Clinical Doctoral Research
Fellowship
Trainees Coordinating Centre
• Enable health and social care
practitioners to develop skills
to design and lead high quality
clinical research
• Research relevant to
patients/clients & NHS priorities
• Facilitate practitioner careers
combining clinical research and
research leadership with
developing clinical practice
For more information:
Visit:
http://www.uclan.ac.uk/study_here
/
postgraduate_study.php
Email: Dr Lois Thomas
lhthomas@uclan.ac.uk
INTERNSHIPS
 LINCS - 2010
Lancashire Initiative for Nursing and Caring research in Stroke: Oral Flora (4
LTHTR staff)
 HENW – 2013-2016
Range of projects (10 staff) annually
 CLAHRCS - 2014
Range of projects (10 staff) & now 15 annually
 Senior Investigator/RCF - 2016
Range of projects – Grass Roots Care (4 LTHTR staff)
Changes in Oral Flora in Acute Stroke:
An observational study
Professor Caroline Watkins
University of Central Lancashire
United Kingdom Swallow Research Group
February 2016
Stroke
• UK: 150,000 people/annum
• Top 3 cause of death
• Leading cause of adult disability
• 1/5 acute hospital beds
• Increased risk of respiratory infection-first few weeks
• Risk of infection mostly more dependent patients
• 10% of stroke patients develop pneumonia
• Pneumonia associated with death (OR 3.62)
• Pneumonia potentially linked to poor oral hygiene
Current oral care practices
• Poor oral health within supported care (Hally, 2003)
• Low priority in the hierarchy of care (Adams, 1996)
• Nursing staff dislike oral care (Boyle, 1992)
• Often delegated to care assistants (Wårdh, 1997)
• Lack of knowledge and equipment (Wårdh et al 2000)
• Lack of evidence relating to oral care interventions (Brady, 2006)
Why is oral care important to stroke patients?
Unable to attend to oral hygiene due
to Physical and cognitive problems
Contributing factors following stroke
• Dysphagia with increased risk of
aspiration of bacteria laden saliva
• Facial weakness
• Food Debris in mouth
• Medication
• Oxygen therapy
• Dehydration/Taste
• Mouth Breathing
• Inability to recognise need for oral care
• Inability for express need for oral care
• Hemiplegia
• Decreased oral sensation
Oral Flora
• Complex
bionetwork
• High diversity of
oral flora
• Disruption to oral
cleanliness may
lead to overgrowth
of pathogenic
bacteria
Thick plaque forms
Gums are very red and swollen.
This person has gum disease
If plaque is not removed it will
harden to become tartar
(calculus)
Tooth decay
Aims
1. Identify patient characteristics and clinical
factors e.g.infection, that may affect oral flora
2. Describe bacterial profile of oral flora during
the first two weeks post-stroke
3. Examine changes in condition of oral cavity
Procedure
• Time Point 1: <48 hs post-admission
Patient characteristics i.e. demographic data
Clinical data (documentation of infection)
Oral DNA samples
Oral assessment using THROAT
• Time Point 2: 48-72 hs after time point one
Clinical data (documentation of infection)
Oral DNA samples
Oral assessment using THROAT
• Time Point 3: 7 days post-admission
Clinical data (documentation of infection)
Oral DNA samples
Oral assessment using THROAT
International Stroke Research Collaboration (ISReC)
1. Patient characteristics & Clinical factors
0
2
4
6
8
10
12
Time point one Time point Two Time point Three
Respiratory
Oral
UTI
Cellulitus
Septacaemia
2. Oral bacterial profile
• 103 bacterial phylotypes were isolated (98-100% sequence
similarity cut-off for defining a phylotype)
• 29 of which are considered to be non-oral flora
• Of 367 samples, 211 (57.5%) Streptococcus genus
• Abnormal Streptococcus phylotypes occurred in 23 (11%)
samples.
• Average number of different bacterial phylotypes/person
2.72, 2.76 and 2.32 at time points 1, 2 and 3 respectively
(range 0 – 11)
• No significant difference in the average number of different
phylotypes found across all three time points
3. Condition of the oral cavity over three time points
Thank you
Acknowledgements:
• Dr Louise Connell
• Dr Liz Boaden
• Wendy Loughlin
• Annette Munro
• Dr Hazel Dickinson
• Karen Shevlin
• Dr Craig Smith
• Dr Liz Lightbody
• Dr Michael Leathley
• Alison McLoughlin
• Mary Lyons
• Simarjit Singhrao
• Zarine Khan
• Prof StJohn Crean
British Journal of
Healthcare Assistants
November 2013 Vol
07 No 11
47
Stroke Care
• High quality stroke care is care that is right for that
patient at that point on their care pathway
• To deliver the right care staff must have the right
– Knowledge
– Skills
– Abilities
– Time
EVIDENCE-
BASED
CARE
Knowledge?
• It ain’t what you know that gets you into trouble
• It’s what you know for sure that just ain’t so
Mark Twain
Funding from the National Health and Medical Research Council
(NHMRC) of Australia
An international collaborative project
Sitting up is the typical nursing position for
patients in the UK
Lying flat is common in some
countries
China
Switzerland
Lying flat is standard care for acute ischaemic
stroke in hospitals in Switzerland
Day Mobilisation schedule Importance
1 Bedrest/lying flat strict
2 Bedrest head 30 degrees strict
3 Bedrest head 60 degrees strict
4 Sitting on edge of bed
(accompanied during care)
5 Sitting in a chair
(accompanied during care)
6 Walking around in the
room (with care assistant)
7 Walking around freely
Balance of potential benefits and risks
of sitting up vs lying flat
Sat up
• Reduce cerebral oedema,
especially in ICH or
malignant MCA infarction
• Improve cardiac function
• Improve oxygenation
• Increase alertness
Lying down
• Improve collateral cerebral
blood flow
 arterial
 venous
• Rest the brain
Overview
An international, multicentre, cluster
randomised, crossover, blinded outcome
assessment trial to compare the lying flat with
sitting up in acute stroke
Trial Schema
Lying Flat Head Positioning
0° for first 24 hours
Sitting Up Head Positioning
≥30° for first 24 hours
Randomisation
Sitting Up Head Positioning
≥30° for first 24 hours
Lying Flat Head Positioning
0° for first 24 hours
STUDY SITES
Standard
Nursing and
Medical
Care
(Local
Guidelines)
Crossover Crossover
Blinded assessment of outcome at 90 days
Blinded assessment of
outcome at 90 days
Why a cluster cross-over design?
Cluster
• To avoid contamination, patients will not see differences in
practice
• Better compliance from both staff and patients
Cross-over
• Internally adjusts for background variation across hospitals
• All hospitals will change practice from usual policy, thus
internally adjusting for ‘change’
• Fewer centres needed
• Reduce sample size by ≥30%
Consent
• Cluster guardian
– No consent to the intervention, the intervention will be the “usual
care” at that time point
– Necessary to prevent contamination of the intervention
– Insufficient evidence for a specific ideal head position
– Head position in both groups within the range of routine practice
• Individual patient consent
– Consent for data collection (in-hospital data)
– As soon as possible
– Centralised 90 days follow-up assessments
Results
• >100 sites worldwide
• 41 UK sites
• >10,000 patients worldwide
• ~4000 UK patients
• 3rd European Stroke Organisation
Conference 2017, Prague, 16-18th May
Implementing Research:
Everybody’s
business?
Patient
Research
Nurse/Coordinator
Clinician
Manager
Researcher
Key Message
Research is for patients
and not clinicians or researchers……..
Key to success is working together!
Research Support Team rsenquiries@uclan.ac.uk

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Caroline Watkins

  • 1. Caroline Watkins Professor of Stroke & Older People’s Care Director of Research and Innovation, College of Health and Wellbeing University of Central Lancashire Preston, UK & Australian Catholic University, Sydney clwatkins@uclan.ac.uk Participation in Health Research: Edge walking?
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  • 11. Research priorities those of clinicians? “Practitioners will continue to ignore research publications until they are seen as helpful and relevant” Sobell (1996)
  • 12. Key Message Today’s research is tomorrow’s care……
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  • 14. Trainees Coordinating CentreTrainees Coordinating Centre National Institute for Health Research Established 2006: A vehicle for implementing Government’s strategy for applied health research £1bn annual spend Vision: Improving health and wealth of nation through research
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  • 16. Trainees Coordinating CentreTrainees Coordinating Centre NIHR Remit • People and patient based applied health research • Research capacity to improve health/healthcare • Patients, samples or data from patients, people who are not patients, populations, health technology assessment and health services research • The potential to have an impact on the needs of patients and the public within 5 years of completion • Prepared to support research into medical education • No basic research involving animals and/or animal tissue
  • 17. Trainees Coordinating Centre Research Training Opportunities from NIHR David Richards, PenCLAHRC, University of Exeter Medical School (additional material from Peter Thompson, NIHR TCC)
  • 20. Trainees Coordinating CentreTrainees Coordinating Centre NIHR Fellowships Programme • Salary • Full tuition fees (for PhD) • Research costs • Full training and development • Awards 3 years full time (part-time options of 75% or 60%) or up to 5 years for SRF • Can be based at HEI or NHS Trust • Annual competition for all levels • Next launch – October 2016
  • 21. Trainees Coordinating CentreTrainees Coordinating Centre Post Doctoral Research Fellowship (NIHR PDF) Early post doctoral Fellowship (≤ 3 years WTE Post Doctorate) 3 years FT (4 or 5 years PT) Applicant: PhD/MD or have submitted Output from research Evidence of commitment to research career Doctoral training award 3 years FT (4 or 5 years PT) Applicant: Some previous research experience Some outputs from research Evidence of commitment to research career Doctoral Research Fellowship (NIHR DRF) NIHR Fellowships
  • 22. Trainees Coordinating CentreTrainees Coordinating Centre Senior Research Fellowship (NIHR SRF) Most senior NIHR Fellowship 5 years ( Chair) Applicant: Significant postdoctoral experience Outstanding publication record Independence Leadership potential Record of research capacity development Later postdoctoral award (≤ 7 yrs WTE Post Doctorate) 3 years FT (4 or 5 years PT) Applicant: PhD/MD and postdoctoral experience Significant output from research Evidence of increasing independence Experience of developing research skills of others Career Development Fellowship (NIHR CDF) NIHR Fellowships
  • 23. Trainees Coordinating CentreTrainees Coordinating Centre NIHR Fellowships Postdoctoral award (≤ 5 yrs WTE Post Doctorate) 18 months to 2 years FT or PT Applicant: PhD/MD and maybe postdoctoral experience • Individuals from any scientific discipline wanting to contribute to improving health or healthcare e.g. basic scientists moving to applied health research • Individuals who have had their research careers interrupted e.g. career break, who can identify clear training needs • Proposed research must be within the NIHR remit Transitional Research Fellowship (NIHR TRF) new from 2013
  • 24. Trainees Coordinating CentreTrainees Coordinating Centre HEE/NIHR Integrated Clinical Academic Programme Health Education England Review recommended expansion to all registered non medical/dental registered healthcare professionals committed to developing a career which combines research and continued clinical practice.
  • 26. Trainees Coordinating CentreTrainees Coordinating Centre HEE/NIHR Integrated Clinical Academic Programme • Funded HEIs advertise places (institutional award) • 100 places per annum available over next 3 years • The University of Manchester • University of Nottingham • University of Leeds • The City University London • University of Southampton • University of Brighton • Kingston University London • University of Plymouth • University of East Anglia • Coventry University • PhD research whilst developing clinical skills • Based at English NHS trust, other health care organisation or HEI • Min 1 yr clinical experience and current statutory registration • Need for both a good academic and clinical supervisor • Salary, PhD tuition fees, research, training & development costs (100% NHS, 80% HEI except training & development @100%) • 3 years FT (4 or 5 years PT) • Next call March 2017 HEE/NIHR Masters in Clinical Research HEE/NIHR Clinical Doctoral Research Fellowship
  • 27. Trainees Coordinating Centre Good Applications 1. Applicant • (trajectory, career outputs) 2. Research Project • (scientific quality, appropriate scale and scope) 3. Training and Development • (meet the needs of the candidate and the project) 4. Environment • (research Excellence Framework rating, facilities) 5. Supervision/mentorship • (track record in relevant field, time and commitment)
  • 28. Trainees Coordinating Centre Project • Doable • Applied • Relevant • Five year impact rule • Quality high • PPI – VETO ALERT! – Do not confuse PPI with focus groups and qualitative data – that’s different (so don’t include that piece in the PPI section). PPI is actual involvement in the research process itself. – PPI is NOT people as research participants/subjects giving data
  • 29. Trainees Coordinating CentreTrainees Coordinating Centre HEE/NIHR Integrated Clinical Academic Programme • Funded HEIs advertise places (institutional award) • 100 places per annum available over next 3 years • The University of Manchester • University of Nottingham • University of Leeds • The City University London • University of Southampton • University of Brighton • Kingston University London • University of Plymouth • University of East Anglia • Coventry University • PhD research whilst developing clinical skills • Based at English NHS trust, other health care organisation or HEI • Min 1 yr clinical experience and current statutory registration • Need for both a good academic and clinical supervisor • Salary, PhD tuition fees, research, training & development costs (100% NHS, 80% HEI except training & development @100%) • 3 years FT (4 or 5 years PT) • Next call March 2017 HEE/NIHR Masters in Clinical Research HEE/NIHR Clinical Doctoral Research Fellowship
  • 30. Trainees Coordinating Centre • Enable health and social care practitioners to develop skills to design and lead high quality clinical research • Research relevant to patients/clients & NHS priorities • Facilitate practitioner careers combining clinical research and research leadership with developing clinical practice For more information: Visit: http://www.uclan.ac.uk/study_here / postgraduate_study.php Email: Dr Lois Thomas lhthomas@uclan.ac.uk
  • 31. INTERNSHIPS  LINCS - 2010 Lancashire Initiative for Nursing and Caring research in Stroke: Oral Flora (4 LTHTR staff)  HENW – 2013-2016 Range of projects (10 staff) annually  CLAHRCS - 2014 Range of projects (10 staff) & now 15 annually  Senior Investigator/RCF - 2016 Range of projects – Grass Roots Care (4 LTHTR staff)
  • 32. Changes in Oral Flora in Acute Stroke: An observational study Professor Caroline Watkins University of Central Lancashire United Kingdom Swallow Research Group February 2016
  • 33. Stroke • UK: 150,000 people/annum • Top 3 cause of death • Leading cause of adult disability • 1/5 acute hospital beds • Increased risk of respiratory infection-first few weeks • Risk of infection mostly more dependent patients • 10% of stroke patients develop pneumonia • Pneumonia associated with death (OR 3.62) • Pneumonia potentially linked to poor oral hygiene
  • 34. Current oral care practices • Poor oral health within supported care (Hally, 2003) • Low priority in the hierarchy of care (Adams, 1996) • Nursing staff dislike oral care (Boyle, 1992) • Often delegated to care assistants (Wårdh, 1997) • Lack of knowledge and equipment (Wårdh et al 2000) • Lack of evidence relating to oral care interventions (Brady, 2006)
  • 35. Why is oral care important to stroke patients? Unable to attend to oral hygiene due to Physical and cognitive problems Contributing factors following stroke • Dysphagia with increased risk of aspiration of bacteria laden saliva • Facial weakness • Food Debris in mouth • Medication • Oxygen therapy • Dehydration/Taste • Mouth Breathing • Inability to recognise need for oral care • Inability for express need for oral care • Hemiplegia • Decreased oral sensation
  • 36. Oral Flora • Complex bionetwork • High diversity of oral flora • Disruption to oral cleanliness may lead to overgrowth of pathogenic bacteria
  • 37. Thick plaque forms Gums are very red and swollen. This person has gum disease If plaque is not removed it will harden to become tartar (calculus) Tooth decay
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  • 39. Aims 1. Identify patient characteristics and clinical factors e.g.infection, that may affect oral flora 2. Describe bacterial profile of oral flora during the first two weeks post-stroke 3. Examine changes in condition of oral cavity
  • 40. Procedure • Time Point 1: <48 hs post-admission Patient characteristics i.e. demographic data Clinical data (documentation of infection) Oral DNA samples Oral assessment using THROAT • Time Point 2: 48-72 hs after time point one Clinical data (documentation of infection) Oral DNA samples Oral assessment using THROAT • Time Point 3: 7 days post-admission Clinical data (documentation of infection) Oral DNA samples Oral assessment using THROAT
  • 41. International Stroke Research Collaboration (ISReC)
  • 42. 1. Patient characteristics & Clinical factors 0 2 4 6 8 10 12 Time point one Time point Two Time point Three Respiratory Oral UTI Cellulitus Septacaemia
  • 43. 2. Oral bacterial profile • 103 bacterial phylotypes were isolated (98-100% sequence similarity cut-off for defining a phylotype) • 29 of which are considered to be non-oral flora • Of 367 samples, 211 (57.5%) Streptococcus genus • Abnormal Streptococcus phylotypes occurred in 23 (11%) samples. • Average number of different bacterial phylotypes/person 2.72, 2.76 and 2.32 at time points 1, 2 and 3 respectively (range 0 – 11) • No significant difference in the average number of different phylotypes found across all three time points
  • 44. 3. Condition of the oral cavity over three time points
  • 45. Thank you Acknowledgements: • Dr Louise Connell • Dr Liz Boaden • Wendy Loughlin • Annette Munro • Dr Hazel Dickinson • Karen Shevlin • Dr Craig Smith • Dr Liz Lightbody • Dr Michael Leathley • Alison McLoughlin • Mary Lyons • Simarjit Singhrao • Zarine Khan • Prof StJohn Crean
  • 46. British Journal of Healthcare Assistants November 2013 Vol 07 No 11
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  • 48. Stroke Care • High quality stroke care is care that is right for that patient at that point on their care pathway • To deliver the right care staff must have the right – Knowledge – Skills – Abilities – Time
  • 50. Knowledge? • It ain’t what you know that gets you into trouble • It’s what you know for sure that just ain’t so Mark Twain
  • 51. Funding from the National Health and Medical Research Council (NHMRC) of Australia An international collaborative project
  • 52. Sitting up is the typical nursing position for patients in the UK
  • 53. Lying flat is common in some countries China Switzerland
  • 54. Lying flat is standard care for acute ischaemic stroke in hospitals in Switzerland Day Mobilisation schedule Importance 1 Bedrest/lying flat strict 2 Bedrest head 30 degrees strict 3 Bedrest head 60 degrees strict 4 Sitting on edge of bed (accompanied during care) 5 Sitting in a chair (accompanied during care) 6 Walking around in the room (with care assistant) 7 Walking around freely
  • 55. Balance of potential benefits and risks of sitting up vs lying flat Sat up • Reduce cerebral oedema, especially in ICH or malignant MCA infarction • Improve cardiac function • Improve oxygenation • Increase alertness Lying down • Improve collateral cerebral blood flow  arterial  venous • Rest the brain
  • 56. Overview An international, multicentre, cluster randomised, crossover, blinded outcome assessment trial to compare the lying flat with sitting up in acute stroke
  • 57. Trial Schema Lying Flat Head Positioning 0° for first 24 hours Sitting Up Head Positioning ≥30° for first 24 hours Randomisation Sitting Up Head Positioning ≥30° for first 24 hours Lying Flat Head Positioning 0° for first 24 hours STUDY SITES Standard Nursing and Medical Care (Local Guidelines) Crossover Crossover Blinded assessment of outcome at 90 days Blinded assessment of outcome at 90 days
  • 58. Why a cluster cross-over design? Cluster • To avoid contamination, patients will not see differences in practice • Better compliance from both staff and patients Cross-over • Internally adjusts for background variation across hospitals • All hospitals will change practice from usual policy, thus internally adjusting for ‘change’ • Fewer centres needed • Reduce sample size by ≥30%
  • 59. Consent • Cluster guardian – No consent to the intervention, the intervention will be the “usual care” at that time point – Necessary to prevent contamination of the intervention – Insufficient evidence for a specific ideal head position – Head position in both groups within the range of routine practice • Individual patient consent – Consent for data collection (in-hospital data) – As soon as possible – Centralised 90 days follow-up assessments
  • 60. Results • >100 sites worldwide • 41 UK sites • >10,000 patients worldwide • ~4000 UK patients • 3rd European Stroke Organisation Conference 2017, Prague, 16-18th May
  • 62. Key Message Research is for patients and not clinicians or researchers……..
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  • 65. Key to success is working together! Research Support Team rsenquiries@uclan.ac.uk