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Trials in Secondary progressive
multiple sclerosis
design & efficiency
Jeremy Chataway
Queen Square MS Centre
National Hos...
The talk
1. What is Progression?
2. How would an anti-progressive drug be
found?
3. What outcome would be measured?
4. Wha...
Symptoms
• Eye problems
Double vision
Balance
Bladder
Fatigue

•Weakness
What’s going on?
Cum. Probability of Relapse

RR stage almost containable?
0.6

Hazard ratio = 0.50
P<0.0001

0.5

Avonex +
Placebo

0.4
Av...
Many new drugs here/coming very
soon
•

•

•

•
•

Prevention of T cell circulation and transmigration
– Natalizumab
– Fin...
Playing the long game
>60%
MS Onset
30ys

SPMS onset
45-50yrs
The progression
In MS? - Say walking

Primary/Secondary
ECTRIMS 2013-can we define SPMS
early: MSBase n~3550/21000; median
8-9yrs follow-up
•
•
•

D1) Physician designation
D2) f...
Predictors of progression
Up to EDSS 4.0
–
–
–
–
–

Older age of onset
Cord onset>brainstem>visual/sensory
Incomplete reco...
SPMS pathology
Demyelination
Neuronal/
Axonal loss
Gliosis

Trapp Lancet Neurology 2009
Mechanisms
• Oligodendrocyte loss/demyelination
• Energy failure
• Reactive oxygen/nitric oxide species
• Excitotoxicity
Trials
a rough guide
Words
•
•
•
•

What’s a trial
Placebo
Phase
Randomisation
Doing a trial (running a race)
• Runners & riders [drugs]
• Course [eg 2-3 years]
• Measure [eg MRI/disability]
Two horse race
What’s a placebo?
Early stage: beta-interferon
What’s a phase?
Randomisation
Doing a trial in SPMS
1. Runners & riders [drugs]
2. Measure [outcome]
3. Course type [length/time]
1.Find a drug
Find a drug-animal data
Find a drug?
Find a drug - human
Ibudilast
Riluzole
• Phase IIa: 16 patients with Progressive MS were studied
1 year before treatment, followed by riluzole 50mg bd f...
Amiloride
2.Measuring what you’ve done
• Clinical
– EDSS
– MSFC
– MSIS29
– MSWS

• Surrogate
EDSS – problem child
MRI in Progressive Disease
Whole brain segmentation
in Native Space

3D rendered image

Whole brain
volumes generated
•

T...
Baseline
Registered Year 2
Screening showing
BBSI colour overlay
Novel MRI methods
3.Course design
Repeatedly negative (n~5000)
Big money!: Dirucotide (MBP)
• ‘BioMS Medical terminates exclusive
licensing agreement with Eli Lilly for
dirucotide’
Lessons learnt
Lamotrigine-pseudoatrophy
CCV linear over time with modelled pivot at 6months

Monthly mean EDSS

by tablet compliant comp...
CUPID

12 month follow-up (80%)

To finish….
And can turn out negative (phase III): 2013
We need this in SP/PPMS
Multi-arm Multi-stage (MAMS)
Multi-arm (Multi-stage)
STAMPEDE
Dropping and adding
Adaptive trial designs
•
•
•
•
•
•
•
•
•
•

Adaptive randomization design
Group sequential design
Flexible sample size re-...
MS Trial Design
e.g. Design for 4 test treatments and 1 control (placebo)

1
4 Phase 2
2
Trials

3

2 Phase 3
Trials

Stag...
Linkage

F
I

MRI
0

EDSS

0

6

12

Δ MRI

18

24

30

Crucial data

Interim

36
Embracing Repurposing
Advantages
• Drug known in detail eg AE
• Better phase II [25% vs 10%] and phase
III success [65% vs 50%] than new
molecul...
Examples
Trial Design
Our Work for 2014!

Stage 2 cohort

e.g. Design for 4 test treatments and 1 control (placebo)

1
3 Phase 2
2
...
Primary Objective
 Volumetric MRI (Siena)

Secondary Objectives
 Disability (EDSS/MSIS29v2/MSFC/MSWSv2/SDMT/SLCVA)
 EQ5...
Patient Flow
0

6m

2yr

1yr

-30d
EDSS

EDSS

MSIS29v2

MSIS29v2

MSIS29v2

MSFC

MSFC

MSFC

MSWSv2
Safety

EDSS

MSWSv2...
440 people
SPMS
UK
Inclusion Criteria









Confirmed diagnosis of SPMS at randomisation
Steady progression rather than relapse maj...
Exclusion Criteria
•
•
•
•
•
•
•
•
•
•

Significant organ co-morbidity (e.g. malignancy/ renal or hepatic failure)
Routine...
Exploratory Outcomes







Advanced MRI
T1hypointensity
GM
MTR
MRS
Cervical cord

 OCT
 CSF Neurofilament levels
Centres

Glasgow

Edinburgh
Newcastle

Sheffield

Liverpool

Nottingham
North
Staffordshire
Oxford

London – 3 sites

TTT
...
Meanwhile
MS-STAT trial
High dose oral Simvastatin
in Secondary Progressive Multiple Sclerosis
Jeremy Chataway
for the MS-...
Institutions
•

Clinical Assessments: Imperial College Healthcare NHS Trust,
UCLH NHS Foundation Trust, Brighton and Susse...
People
Clinical Fellows: Ali Alsanousi, Imran Saddiqi, Rosella Padama, Paulo Giannetti,
Miriam Mattoscio
Trial Managers: D...
Why Simvastatin and MS?
Inflammation in SPMS
Mechanism
Baseline
Registered Year 2
Screening showing
BBSI colour overlay
Worked example in MS (phase II)
MS-STAT trial
High dose (80mg) simvastatin
Mean (SD)
placebo

Mean (SD)
simvastatin

Diffe...
Change whole brain volume (%/yr)
Change in EDSS 0 to 24 months

Change in EDSS from Baseline to 24 months
Conclusions
• MS is very hard
• But the RR phase maybe almost dealt with
• Drug choice will become
broader/combinatorial
•...
Thank you
NHS reforms –
opportunities and
challenges for MS Care

Karen Middleton CBE
Chief Allied Health
Professions Officer
Summary
• Context - the narrative for the reforms
• The key structures that clinicians need to be
aware of
• Key messages
...
Some NHS facts and figures
•
•
•
•
•
•

82

1.3 million staff
£109 billion annual budget
Over 1 million patients treated e...
Context

83
Context – Quality (safe, effective, good experience)
‘In the next room you could hear the buzzers sounding. After
about 20...
85
Commissioning of services

86
First Mandate for NHS England
•First Mandate published on 13th November
2012
•Sets out what the Government expects in
retu...
NHS Mandate

88
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/127193/mandate.pdf.pdf
Tools and levers of the Quality Framework

89
NHS ENGLAND
Our focus – delivering improved outcomes

The NHS
Outcomes
Framework

90
How we align these tools and levers will be key to
success

91
NHS Outcomes Framework ‘At a Glance’
1

Preventing people from dying prematurely

Overarching indicators
1a Potential Year...
Key work programmes
1.Prevention, early diagnosis and intelligence
2.Community services
3.Acute services
4.Integrated care...
Clinical Senates

94
12 Clinical Senates
North East, north Cumbria,
and the Hambleton &
Richmondshire districts of
North Yorks

Yorkshire &
The...
Strategic Clinical Networks (SCNs)

96
Innovation
‘An idea, service or product,
new to the NHS
or applied in a way
that is new to the NHS,
which significantly im...
Academic Health Science Networks
• 15 – designated and licensed
• 5 year contracts
• Systematic delivery mechanism for dif...
AHSNs
Academia

99

Industry

Oxford
Eastern
Wessex
UCL Partners
South London
East Midlands
West Midlands
West of England
...
Health Education England
• National
• Local – 13 Local Education training Boards (LETBs or
HEELs)
Purpose:
To support the ...
HEE advisory arrangement

PAF
PAF

Exec

101

Primary Decision Making Body/ Overarching Governance
HEE Advisory & Decision...
Key messages

• Stop looking up for direction and guidance
• It really is a commissioning-led system
• Understand patient ...
Challenges
• Doing more for less – or doing different for less
• Transformational rather than transactional change
• Gener...
Opportunities
• The focus on outcomes
• Rehab, rehab, rehab!
• Multi-disciplinary approach
• Patient voice

104
Exerting influence
•
•
•
•
•
•
•
•
•
105

Put yourself in the shoes of the other person
Avoid perception of self-interest
...
A final great thought from a great inspiration…

”When you are done

changing, you are done”

Benjamin Franklin

4
Thank you
Karen.middleton1@nhs.net
karen@chpo

107
Trials in secondary progressive multiple sclerosis: design & efficiency
Trials in secondary progressive multiple sclerosis: design & efficiency
Trials in secondary progressive multiple sclerosis: design & efficiency
Trials in secondary progressive multiple sclerosis: design & efficiency
Trials in secondary progressive multiple sclerosis: design & efficiency
Trials in secondary progressive multiple sclerosis: design & efficiency
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Trials in secondary progressive multiple sclerosis: design & efficiency

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This presentation by Dr Jeremy Chataway looks at:
- What is MS progression?
- How would an anti-progressive drug be found?
- What outcome would be measured?
- What trial design could/would be used?
- Where are we now?

It was presented at the MS Trust Annual Conference in November 2013.

Veröffentlicht in: Gesundheit & Medizin, Business
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Trials in secondary progressive multiple sclerosis: design & efficiency

  1. 1. Trials in Secondary progressive multiple sclerosis design & efficiency Jeremy Chataway Queen Square MS Centre National Hospital for Neurology and Neurosurgery, UCLH, London
  2. 2. The talk 1. What is Progression? 2. How would an anti-progressive drug be found? 3. What outcome would be measured? 4. What trial design could/would be used? 5. Where are we now?
  3. 3. Symptoms • Eye problems Double vision Balance Bladder Fatigue •Weakness
  4. 4. What’s going on?
  5. 5. Cum. Probability of Relapse RR stage almost containable? 0.6 Hazard ratio = 0.50 P<0.0001 0.5 Avonex + Placebo 0.4 Avonex + Natalizumab 0.3 0.2 0.1 0.0 Alemtuzumab 0 12 24 36 Weeks 48 60 Number of Patients at Risk 582 589 474 528 401 483 339 437 235 307 118 170
  6. 6. Many new drugs here/coming very soon • • • • • Prevention of T cell circulation and transmigration – Natalizumab – Fingolimod Anti-metabolities – Teriflunomide – Cladibrine [Phase III completed] Leukocyte depletion – Alemtuzumab – Daclizumab [Phase III] B-cell directed therapies – Ocreluzimab [Phase III] Oral drugs with ambiguous mechanism – Laquinomod – Fumarate
  7. 7. Playing the long game >60% MS Onset 30ys SPMS onset 45-50yrs
  8. 8. The progression
  9. 9. In MS? - Say walking Primary/Secondary
  10. 10. ECTRIMS 2013-can we define SPMS early: MSBase n~3550/21000; median 8-9yrs follow-up • • • D1) Physician designation D2) first EDSS of 4 or more D3) first EDSS of 3 or more associated with at least one 1-point EDSS progression event within the 2 years prior to this onset date • Identification of SPMS phase by physicians occurs 4 to7 years later when compared with pure EDSS based definitions • Physician designation of SPMS is more specific than EDSS-based definitions, but occurs later
  11. 11. Predictors of progression Up to EDSS 4.0 – – – – – Older age of onset Cord onset>brainstem>visual/sensory Incomplete recovery from initial index event ?early second event ?frequency of attacks first 2-5 yrs • From EDSS 4.0 – Unclear • Not as clear as you might think!
  12. 12. SPMS pathology Demyelination Neuronal/ Axonal loss Gliosis Trapp Lancet Neurology 2009
  13. 13. Mechanisms • Oligodendrocyte loss/demyelination • Energy failure • Reactive oxygen/nitric oxide species • Excitotoxicity
  14. 14. Trials a rough guide
  15. 15. Words • • • • What’s a trial Placebo Phase Randomisation
  16. 16. Doing a trial (running a race) • Runners & riders [drugs] • Course [eg 2-3 years] • Measure [eg MRI/disability]
  17. 17. Two horse race
  18. 18. What’s a placebo?
  19. 19. Early stage: beta-interferon
  20. 20. What’s a phase?
  21. 21. Randomisation
  22. 22. Doing a trial in SPMS 1. Runners & riders [drugs] 2. Measure [outcome] 3. Course type [length/time]
  23. 23. 1.Find a drug
  24. 24. Find a drug-animal data
  25. 25. Find a drug?
  26. 26. Find a drug - human
  27. 27. Ibudilast
  28. 28. Riluzole • Phase IIa: 16 patients with Progressive MS were studied 1 year before treatment, followed by riluzole 50mg bd for 1 year. • Primary outcome was change in cervical spinal cord cross-sectional area that showed a reduction from -2% (yr 1) to -0.2% (yr 2). • In addition the increase in T1 hypointense lesion load was reduced from 15% in year 1 to 6% in year 2 • and reduction in whole brain parenchymal/intracranial volume went from -1.0% (yr 1) to -0.7% (yr2). Killestein J, Kaljers NF, Polman CH, et al. Glutamate inhibition in MS: the neuroprotective properties of riluzole.J Neurol Sci 2005;233:113–115
  29. 29. Amiloride
  30. 30. 2.Measuring what you’ve done • Clinical – EDSS – MSFC – MSIS29 – MSWS • Surrogate
  31. 31. EDSS – problem child
  32. 32. MRI in Progressive Disease Whole brain segmentation in Native Space 3D rendered image Whole brain volumes generated • Then repeat and screening scans are registered using a 12dof affine registration. – Linear transformation (rotation, translation, scaling and shear) to spatially align repeat scan to the baseline scan. • This registration step allows for the automatic quantification of longitudinal changes with the BSI (Boundary Shift Integral).
  33. 33. Baseline
  34. 34. Registered Year 2
  35. 35. Screening showing BBSI colour overlay
  36. 36. Novel MRI methods
  37. 37. 3.Course design
  38. 38. Repeatedly negative (n~5000)
  39. 39. Big money!: Dirucotide (MBP) • ‘BioMS Medical terminates exclusive licensing agreement with Eli Lilly for dirucotide’
  40. 40. Lessons learnt
  41. 41. Lamotrigine-pseudoatrophy CCV linear over time with modelled pivot at 6months Monthly mean EDSS by tablet compliant comparison 260000 by ITT comparison 6.4 255000 EDSS (score) CCV 6.2 250000 245000 6 5.8 -6 0 6 e6_months 12 Active 18 5.6 24 Placebo 57 61 56 56 57 54 56 49 57 52 0 240000 6 12 month 18 24 Active Placebo Bars show standard error around mean Numbers of valid monthly observations shown Monthly mean TWT by ITT comparison .1 TWT (1/sec) .09 .08 A. .07 61 57 56 56 54 56 49 55 52 56 0 .06 6 12 month 18 24 Active Bars show standard error around mean Numbers of valid monthly observations shown Kapoor Placebo B. C.
  42. 42. CUPID 12 month follow-up (80%) To finish…. And can turn out negative (phase III): 2013
  43. 43. We need this in SP/PPMS
  44. 44. Multi-arm Multi-stage (MAMS)
  45. 45. Multi-arm (Multi-stage) STAMPEDE
  46. 46. Dropping and adding
  47. 47. Adaptive trial designs • • • • • • • • • • Adaptive randomization design Group sequential design Flexible sample size re-estimation design Drop-the-losers (play-the-winner) design Adaptive dose finding design Biomarker-adaptive design Adaptive treatment-switching design Adaptive-hypotheses design Seamless adaptive trial design Multiple adaptive design
  48. 48. MS Trial Design e.g. Design for 4 test treatments and 1 control (placebo) 1 4 Phase 2 2 Trials 3 2 Phase 3 Trials Stage 1 cohort Chataway J et al: A novel adaptive design strategy increases the efficiency of clinical trials in secondary progressive multiple sclerosis. Multiple Sclerosis 2011; 17: 81-8 52
  49. 49. Linkage F I MRI 0 EDSS 0 6 12 Δ MRI 18 24 30 Crucial data Interim 36
  50. 50. Embracing Repurposing
  51. 51. Advantages • Drug known in detail eg AE • Better phase II [25% vs 10%] and phase III success [65% vs 50%] than new molecular entities • Cost
  52. 52. Examples
  53. 53. Trial Design Our Work for 2014! Stage 2 cohort e.g. Design for 4 test treatments and 1 control (placebo) 1 3 Phase 2 2 Trials 3 2 Phase 3 Trials Stage 1 cohort 57
  54. 54. Primary Objective  Volumetric MRI (Siena) Secondary Objectives  Disability (EDSS/MSIS29v2/MSFC/MSWSv2/SDMT/SLCVA)  EQ5D  New/enlarging lesions T2 MRI  Pseudoatrophy  Relapses  Neuropathic pain  Safety
  55. 55. Patient Flow 0 6m 2yr 1yr -30d EDSS EDSS MSIS29v2 MSIS29v2 MSIS29v2 MSFC MSFC MSFC MSWSv2 Safety EDSS MSWSv2 MSWSv2 1 2 3 6 9 1yr 1.5yr 2yr
  56. 56. 440 people SPMS UK
  57. 57. Inclusion Criteria        Confirmed diagnosis of SPMS at randomisation Steady progression rather than relapse major cause of increasing disability in the preceding 2 years (Progression evident from either an increase of at least one point in EDSS or clinical documentation of increasing disability) Expanded Disability Status Scale (EDSS) 4.0-6.5 Aged 25 to 65 Men or Women of childbearing age must be using an appropriate method of contraception from time of consent, to 6 weeks after treatment Females - negative pregnancy test (as applicable) Willing and able to give full written informed consent Able to undertake MRI
  58. 58. Exclusion Criteria • • • • • • • • • • Significant organ co-morbidity (e.g. malignancy/ renal or hepatic failure) Routine screening blood values Relapse within 3 months of baseline visit Patients who have been treated with iv or oral steroids within 3 months of baseline visit commencement of Fampridine within 6 months of baseline visit Use of immunosuppressants, disease modifying treatments within 6 months of baseline visit Use of fingolimod/fumarate/teriflunomide/laquinomod/or other experimental disease modifying treatment (including research of an investigational medicinal product) within 12 months of baseline Use of mitoxantrone/ natalizumab/ alemtuzumab/ daclizumab if treated within 12 months of baseline visit Use of: lithium, chlorpropamide, triamterene, spironolactone Use of potassium supplements
  59. 59. Exploratory Outcomes      Advanced MRI T1hypointensity GM MTR MRS Cervical cord  OCT  CSF Neurofilament levels
  60. 60. Centres Glasgow Edinburgh Newcastle Sheffield Liverpool Nottingham North Staffordshire Oxford London – 3 sites TTT UCLH, Barts & the London, Imperial T Truro T T Plymouth Brighton/Haywards H
  61. 61. Meanwhile MS-STAT trial High dose oral Simvastatin in Secondary Progressive Multiple Sclerosis Jeremy Chataway for the MS-STAT Collaborators CTN:NCT00647348 EUDRACT NUMBER 2006-006347-31
  62. 62. Institutions • Clinical Assessments: Imperial College Healthcare NHS Trust, UCLH NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust • • MRI analysis: Institute of Neurology, University College London; London School of Hygiene and Tropical Medicine,London • Queen Square MS Centre, University College London • Immunology: Institute of Ophthalmology, University College London • Proteomics: Imperial College,London • Neuropsychology: Brighton and Sussex University
  63. 63. People Clinical Fellows: Ali Alsanousi, Imran Saddiqi, Rosella Padama, Paulo Giannetti, Miriam Mattoscio Trial Managers: David Wilkie, Bella Polito, Jennifer Siegel Trial Pharmacists: Lucy O’Driscoll, Stephanie Steadman MRI: Philippa Bartlett, David MacManus, Kelvin Hunter, Val Anderson, Jo Foster Shona Clegg, Casper Nielsen, Ged Ridgway, Mark Whalley, Nick Fox Statistics: Constantinos Kallis, Chris Frost, Jennifer Nicholas Proteomics: Charles Bangham, Aviva Witkover, Alexandra Lewin Immunology: John Greenwood, Virginia Calder, Nadine Schuerer Psychology: Dennis Chan, Rebecca Cooper, Malaka Awad, Katherine Meadmore, Kirsty Chandler, Kim Marrick RICHARD NICHOLAS
  64. 64. Why Simvastatin and MS?
  65. 65. Inflammation in SPMS
  66. 66. Mechanism
  67. 67. Baseline
  68. 68. Registered Year 2
  69. 69. Screening showing BBSI colour overlay
  70. 70. Worked example in MS (phase II) MS-STAT trial High dose (80mg) simvastatin Mean (SD) placebo Mean (SD) simvastatin Difference in means (95% CI)* p-value Change WBV (%/year) 0.589 (0.528) 0.298 (0.562) -0.254 (-0.423 to -0.085) 0.003 Number patients evaluated 64 66 *Adjusting for minimisation variables and MRI site Chataway et al ECTRIMS 2012; AAN 2013
  71. 71. Change whole brain volume (%/yr)
  72. 72. Change in EDSS 0 to 24 months Change in EDSS from Baseline to 24 months
  73. 73. Conclusions • MS is very hard • But the RR phase maybe almost dealt with • Drug choice will become broader/combinatorial • However whether we can decouple progression is unknown • Progression is very hard to treat • Multiplex-trial [multi-arm/multi-stage] design is needed to quicken drug testing
  74. 74. Thank you
  75. 75. NHS reforms – opportunities and challenges for MS Care Karen Middleton CBE Chief Allied Health Professions Officer
  76. 76. Summary • Context - the narrative for the reforms • The key structures that clinicians need to be aware of • Key messages • Challenges • Opportunities 81
  77. 77. Some NHS facts and figures • • • • • • 82 1.3 million staff £109 billion annual budget Over 1 million patients treated every 36 hours 15 million hospital admissions per year 88 million outpatient attendances C.12 billion spent on medicines
  78. 78. Context 83
  79. 79. Context – Quality (safe, effective, good experience) ‘In the next room you could hear the buzzers sounding. After about 20 minutes you could hear the men shouting for the nurse, ‘nurse, nurse’ and it just went on and on. And then very often you would hear them crying, like shouting ‘nurse’ louder, and then you would hear them crying, just sobbing, they would just sob and you presumed that they had had to wet the bed. And then after they would sob, they seemed to then shout again for the nurse, and then it would go quiet…’ 84
  80. 80. 85
  81. 81. Commissioning of services 86
  82. 82. First Mandate for NHS England •First Mandate published on 13th November 2012 •Sets out what the Government expects in return for handing over £95bn of tax payers money to NHS England •The NHS Outcomes Framework sits at the heart of this Mandate and the Board is expected to demonstrate progress across the entire framework 87 •In turn, the NHS Outcomes Framework sits at the heart of NHS England’s planning guidance ‘Everyone Counts’, published in December 2012
  83. 83. NHS Mandate 88 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/127193/mandate.pdf.pdf
  84. 84. Tools and levers of the Quality Framework 89
  85. 85. NHS ENGLAND Our focus – delivering improved outcomes The NHS Outcomes Framework 90
  86. 86. How we align these tools and levers will be key to success 91
  87. 87. NHS Outcomes Framework ‘At a Glance’ 1 Preventing people from dying prematurely Overarching indicators 1a Potential Years of Life Lost (PYLL) from causes considered amenable to healthcare i Adults ii Children and young people 1b Life expectancy at 75 i Males ii Females Improvement areas Reducing premature mortality from the major causes of death 1.1 Under 75 mortality rate from cardiovascular disease* (PHOF 4.4) 1.2 Under 75 mortality rate from respiratory disease* (PHOF 4.7) 1.3 Under 75 mortality rate from liver disease* (PHOF 4.6) 1.4 Under 75 mortality rate from cancer* (PHOF 4.5) i One- and ii Five-year survival from all cancers iii One- and iv Five-year survival from breast, lung and colorectal cancer Reducing premature death in people with serious mental illness 1.5 Excess under 75 mortality rate in adults with serious mental illness* (PHOF 4.9) Reducing deaths in babies and young children 1.6 i Infant mortality* (PHOF 4.1) ii Neonatal mortality and stillbirths iii Five year survival from all cancers in children Reducing premature death in people with a learning disability 1.7 Excess under 60 mortality rate in adults with a learning disability 2 Enhancing quality of life for people with long-term conditions 3 Helping people to recover from episodes of ill health or following injury Overarching indicators 4 Ensuring that people have a positive experience of care Overarching indicators 3a Emergency admissions for acute conditions that should not usually require hospital admission 3b Emergency readmissions within 30 days of discharge from hospital* (PHOF 4.11) Improvement areas Improving outcomes from planned treatments 3.1 Total health gain as assessed by patients for elective procedures i Hip replacement ii Knee replacement iii Groin hernia iv Varicose veins v Psychological therapies Preventing lower respiratory tract infections (LRTI) in children from becoming serious 3.2 Emergency admissions for children with LRTI 4a Patient experience of primary care i GP services ii GP Out of Hours services iii NHS Dental Services 4b Patient experience of hospital care 4c Friends and family test Improvement areas Improving people’s experience of outpatient care 4.1 Patient experience of outpatient services Improving hospitals’ responsiveness to personal needs 4.2 Responsiveness to in-patients’ personal needs Improving people’s experience of accident and emergency services 4.3 Patient experience of A&E services Improving recovery from injuries and trauma 3.3 Proportion of people who recover from major trauma Improving recovery from stroke 3.4 Proportion of stroke patients reporting an improvement in activity/lifestyle on the Modified Rankin Scale at 6 months Improving recovery from fragility fractures 3.5 Proportion of patients recovering to their previous levels of mobility/walking ability at i 30 and ii 120 days Helping older people to recover their independence after illness or injury 3.6 i Proportion of older people (65 and over) who were still at home 91 days after discharge from hospital into reablement/ rehabilitation service*** (ASCOF 2B) ii Proportion offered rehabilitation following discharge from acute or community hospital Improving access to primary care services 4.4 Access to i GP services and ii NHS dental services Improving women and their families’ experience of maternity services 4.5 Women’s experience of maternity services Improving the experience of care for people at the end of their lives 4.6 Bereaved carers’ views on the quality of care in the last 3 months of life Improving experience of healthcare for people with mental illness 4.7 Patient experience of community mental health services Improving children and young people’s experience of healthcare 4.8 An indicator is under development Improving people’s experience of integrated care 4.9 An indicator is under development *** (ASCOF 3E) Overarching indicator 2 Health-related quality of life for people with long-term conditions** (ASCOF 1A) NHS Outcomes Framework 2013/14 Improvement areas Ensuring people feel supported to manage their condition 2.1 Proportion of people feeling supported to manage their condition** Improving functional ability in people with long-term conditions 2.2 Employment of people with long-term conditions** * (ASCOF 1E PHOF 1.8) Reducing time spent in hospital by people with long-term conditions 2.3 i Unplanned hospitalisation for chronic ambulatory care sensitive conditions (adults) ii Unplanned hospitalisation for asthma, diabetes and epilepsy in under 19s Enhancing quality of life for carers 2.4 Health-related quality of life for carers** (ASCOF 1D) Enhancing quality of life for people with mental illness 2.5 Employment of people with mental illness **** (ASCOF 1F & PHOF 1.8) Enhancing quality of life for 92i Estimated diagnosis rate people with dementia (PHOF 4.16) 2.6 for people with dementia* ii A measure of the effectiveness of post-diagnosis care in sustaining independence and improving quality of life*** (ASCOF 2F) at a glance 5 Treating and caring for people in a safe environment and protect them from avoidable harm Overarching indicators 5a Patient safety incidents reported 5b Safety incidents involving severe harm or death 5c Hospital deaths attributable to problems in care Improvement areas Alignment across the Health and Social Care System * ** Indicator shared with Public Health Outcomes Framework (PHOF) Indicator complementary with Adult Social Care Outcomes Framework (ASCOF) *** Indicator shared with Adult Social Care Outcomes Framework **** Indicator complementary with Adult Social Care Outcomes Framework and Public Health Outcomes Framework Indicators in italics are placeholders, pending development or identification Reducing the incidence of avoidable harm 5.1 Incidence of hospital-related venous thromboembolism (VTE) 5.2 Incidence of healthcare associated infection (HCAI) i MRSA ii C. difficile 5.3 Incidence of newly-acquired category 2, 3 and 4 pressure ulcers 5.4 Incidence of medication errors causing serious harm Improving the safety of maternity services 5.5 Admission of full-term babies to neonatal care Delivering safe care to children in acute settings 5.6 Incidence of harm to children due to ‘failure to monitor’
  88. 88. Key work programmes 1.Prevention, early diagnosis and intelligence 2.Community services 3.Acute services 4.Integrated care and support 5.Patients in control 6.Parity of esteem 93
  89. 89. Clinical Senates 94
  90. 90. 12 Clinical Senates North East, north Cumbria, and the Hambleton & Richmondshire districts of North Yorks Yorkshire & The Humber Greater Manchester, Lancashire and south Cumbria East Midlands Cheshire & Mersey East of England West Midlands Thames Valley London South West South East Coast 95 Wessex
  91. 91. Strategic Clinical Networks (SCNs) 96
  92. 92. Innovation ‘An idea, service or product, new to the NHS or applied in a way that is new to the NHS, which significantly improves the quality of health and care wherever it is applied.’ 97 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_131299
  93. 93. Academic Health Science Networks • 15 – designated and licensed • 5 year contracts • Systematic delivery mechanism for diffusion of innovation and best practice and collaboration between partners including industry • Align education, clinical research, informatics, training and healthcare delivery • Improving patient and population health by translating research into practice and developing and implementing integrated health care systems 98
  94. 94. AHSNs Academia 99 Industry Oxford Eastern Wessex UCL Partners South London East Midlands West Midlands West of England North West Coast Greater Manchester Yorkshire and Humber South West Peninsula Kent, Surrey and Sussex North East and North Cumbria Imperial College Health Partners NHS
  95. 95. Health Education England • National • Local – 13 Local Education training Boards (LETBs or HEELs) Purpose: To support the delivery of excellent healthcare and health improvement by ensuring that our workforce has the right numbers, skills ,values and behaviours, at the right time in the right place. 100
  96. 96. HEE advisory arrangement PAF PAF Exec 101 Primary Decision Making Body/ Overarching Governance HEE Advisory & Decision Making Support Bodies Sub Groups, Special Projects & National Advisory Groups Board Recommendations & decision under scheme of delegation * SLT = HEE Exec & LETB MD’s
  97. 97. Key messages • Stop looking up for direction and guidance • It really is a commissioning-led system • Understand patient power • You have to be bi-lingual • Clinical care has to be paramount • Clinical LEADERSHIP is critical 102
  98. 98. Challenges • Doing more for less – or doing different for less • Transformational rather than transactional change • Generalists versus specialists • Education and training numbers • Reactive versus proactive 103 • Exerting influence – more later!
  99. 99. Opportunities • The focus on outcomes • Rehab, rehab, rehab! • Multi-disciplinary approach • Patient voice 104
  100. 100. Exerting influence • • • • • • • • • 105 Put yourself in the shoes of the other person Avoid perception of self-interest Respect Prepare Build alliances Tell a story Private persuasion over public passion Resilience Wild Cards - Evidence; humour: sprinkling stardust
  101. 101. A final great thought from a great inspiration… ”When you are done changing, you are done” Benjamin Franklin 4
  102. 102. Thank you Karen.middleton1@nhs.net karen@chpo 107

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