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Plenary 3 Ministerial Address
1. Options and Opportunities for Health
Science Innovation in Scotland
DRIVING QUALITY THROUGH INNOVATION
Andrew Morris
Chief Scientist
Scottish Government Health Department
NHS Conference, 22nd June, 2012
2. The next 30 minutes
Current challenges
Gearing an entire
country for quality
health care and research
Information science as
the catalyst for change
The role of academic
health science networks
Case studies
3. The birth of the NHS
“…quite the
most
ambitious
adventure in
the care of
national
health that
any country
Visit of Mark WalportAneurin Bevan, Lancet, July 3 1948
rd
and James Rothman, 15th November, 2007
has seen”
4. Visit of Mark Walport and James Rothman, 15th November, 2007
5. Framingham
1948
All 5,200 town residents
Aged 30-62 years
Regular “health checks”
Three generations of
participants
Iconic epidemiological
study
Visit of Mark Walport and James Rothman, 15th November, 2007
6. What did it tell us?
“Risk factors”
– High blood pressure
– Smoking
– Cholesterol
– Diabetes
Links to heart attacks and
stroke
“Has resulted in an average
of four extra years of life”
C Lenfant, Shattuck Lecture, 2003
Visit of Mark Walport and James Rothman, 15th November, 2007
7. “The Town That Changed
America's Heart”
Visit of Mark Walport and James Rothman, 15th November, 2007
8. The new horizon -
The Human Genome Project
•Map of the three billion letters
that make up the code of life
“It is rather like reaching the
top of a mountain pass and seeing
in front of you a fertile plain,
rich with new ideas, new
methods, new techniques and new
concepts for understanding the
complexity of human biology in
health and disease”
M Bobrow
....and informatics is fundamental to the success of this
revolution in science” A Morris, NHS Conference, June 2012
Visit of Mark Walport and James Rothman, 15th November, 2007
10. DEATHS from CAUSED by:
chronic disease
in 2008:
Up to three quarters of people over 75 years of age currently suffer from a chronic disease
It is estimated that the incidence of chronic disease in the over 65s will double by 2030
Approximately 44% of all chronic disease deaths occur before the age of 70
WHO data show that 75% of the population has one chronic disease…
...and 50% have two or more conditions
Mortality will increase by 17% in next decade and by 25% in Africa and Middle East
11. DIABETES
• Affects 366 million people (6.4% of world population)
• 4 million deaths attributable to diabetes annually
• Number affected will increase to 552 million by 2030
• 80% of current cases occur in low and middle income
countries
• Largest age group affected in 2010 was 40-59 years. This
will move to 60-79 year age group by 2030
• Type 2 diabetes accounts for 85-95% of all diabetes in
high income countries
13. IMPACT ON HEALTHCARE SERVICES
• Patients with a chronic disease use > 60% of hospital bed
days
• Three quarters of patients admitted as medical
emergencies have an exacerbation of a chronic condition
• Patients with three or more chronic conditions (15%)
account for 30% of total inpatient days
• A small number of patients (10%) account for 55% of
total inpatient days
14. ECONOMIC IMPACT
• UN summit 2011 declared chronic diseases to be a global
threat to future sustainability and affordability of
healthcare delivery
• World Economic Forum placed chronic diseases amongst
the most important and severe threats to economic
growth and development
• Institute of Medicine study found that chronic diseases
currently costs developed countries 0.02-6.77% of GDP
• World Economic Forum estimates that chronic diseases
will cost world economy $47 trillion over next 20 years
• Chronic disease management estimated to cost 75% of
GDP by 2030
15. Population-based study
1.75M people in Scotland
42.2% one or more CDs
“Management of patients
with several chronic diseases
is now the most important
task facing health services in
developed countries, which
presents a fundamental
challenge to the single-
disease focus that pervades
medicine”
Lancet May 15th 2012
18. Our Thesis
Quality Health Care and Research: From Cell to Community
NHS Research Scotland
Health Science Scotland
World Class Translation, Excellence
Patient care Trials and In Life
Innovation Sciences
Community Cell
20. Population 5M
Single health care provider
Stability of health structures
High rates of morbidity of common
complex disease
Collaboration –
Aberdeen, Edinburgh, Dundee, Gla
sgow, St Andrews
Layered access
Links to CHI / NHS records
Unique patient identifier records
Prescription
22. Linking Data
- the key to seamless care
Lab Data CHI
AHPs
Pharmacy GP Hospital
Eye Van
Screening
Investigations
23. A National Diabetes
System for Scotland
Total Scottish Population 5.2M
People with diabetes : 251,004
(4.6%)
People with Type 1 DM : ~27,000
(0.5%)
All patients nationally are cared for
with a single clinical information
system SCI-DC
SCI-DC used in all hospitals
Nightly secure sharing of data
from all 1043 primary care
practices across Scotland
28. SCI-DC is a fantastic clinical tool!
Visit of Mark Walport and James Rothman, 15th November, 2007
24 September, 2010
th
29. Scottish Diabetes Survey 2002-2007
Recording of Key Biomedical Markers
Percentage of Patients
Data recoded within the previous 15 months Source: Scottish Diabetes Survey
30. Evidence of improved clinical
outcomes
Diabetic Medicine 2009 Diabetes Care 2008
32. “If you live in Dundee and suffer from
diabetes, you have recently been taking part in
a medical revolution.”
Sir Mark Walport, The Times, 30th May, 2011
33. Is this new?
When you can measure
what you are speaking
about, and express it in
numbers, you know
something about it; but
when you cannot
express it in
numbers, your
knowledge is of a
meagre and
unsatisfactory kind;
Institute of Engineers, 3rd May 1883
Lord Kelvin, 1824-1907
“If you cannot measure it, you cannot improve it”
35. Chronic care management in nine
leading US physician organisations
Puget Sound
Mayo Clinic
Marshfield Clinic
Park Nicollet Clinic
Henry Ford MC
Cleveland Clinic
Kaise Permanante
Inter Mountain Health
Lovelace Clinic
BMJ 2002; 325; 958-61
36. Factors determining
success
Barriers Facilitators
Lack of financial and staff ORGANISATIONAL CULTURE
resources SUPPORTS QUALITY
IMPROVEMENT
LACK OF CLINICAL
ELECTRONIC MEDICAL
INFORMATION SYSTEM
RECORD
Doctors are busy Supportive managerial and
No financial incentive for medical leadership
quality care Support from external
Doctors resist change organisations (Health Plans)
Organisation‟s strategic plan
37. Levels of Information
Assurance
ASSURANCE
Validated Data for 6 domains:
Access, Efficiency, Infection & Prevention, Quality &
Board Patient Experience, Patient Safety and Data Quality
Data and Measurement for
Performance
PERFORMANCE
ET
Validated and un-validated data across 6 domains:
EMT Clinical Excellence, Finance & Activity, Valuing
Staff, Capacity & Activity Planning, Patient Experience
Directorate / CHP and Patient Safety
Improvement
IMPROVEMENT
Ward / Team Level Un-validated data provided in real time through Unified
Patient Tracking, Clinical Portal and operational
Patient / Practitioner Level dashboard with metrics covering Patient Flow, Inpatient
Activity, Out Patients, Waiting Times, Patient Safety,
Infection Control, Clinical Outcomes
Patient to Board
“focusing on information and data to provide assurance on improvement and
quality to deliver better, safer care”.
38. July 2011 compliance with the 62 day cancer target
Number
Number %
Site within
treated Compliance
95% Target Target
Strategic Dashboard
Report Breast 25 25 100%
Cancer Performance Colorectal 14 11 78.6%
Compliance 94.6%
Head & Neck 1 0 0%
Lung 16 16 100%
Cancer 62 days
capability
Gynaecology - Ovarian 4 4 100%
UGI - Hepatopancreastobiliary 2 2 100%
62-day Standard % Compliance 95% HEAT Target UGI - Oesophagogastric 3 3 100%
100 Urology - Bladder 1 1 100%
Compliance Rate
80 Urology – Prostate 8 8 100%
95% HEAT Target
60
Urology – Other 4 4 0%
40
Gynaecology – Cervical 0 0 -
20
0 TOTAL 75 71 94.6%
Nov
Oct
July
Dec
Jan
Aug
'11
Sept
'11
'11
'12
'11
'11
'11
Run Chart showing Commentary
July 2011 –
The figures for July indicate that performance for the 62 day (patients referred urgently with suspected
January 2012 cancer target was 94.7% overall. Performance across all sites was below the 95% HEAT target.
39. Data Information for Improvement
Contains extensive
datasets including
appropriate dates such as
referral, appointment, wait
ing list, waiting times
between stages.
Operational real-time
dashboards
Exploiting existing information
sources
– record information
once, use many times
– deliver information as near
to real time as possible
Focusing on intuitive, user
friendly presentation.
40. The Innovation Pathway
World Class Translation Excellence
Patient care Trials and In Life
Innovation Sciences
Community Cell
http://www.healthsciencescotland.com/
41. Health Science Scotland
• “NHS Scotland‟s new
platform to support
research for patient
benefit and foster
related economic
development”
• Initially four Health
Boards, four
University, SE
Partnership
Launched June 2009; Health Minister and Finance Minister
42. The best clinical research and
innovation laboratory in the
world
NHS Boards Universities
43. Key ingredients for
change
• a strong science infrastructure with vibrant PhD and post
doctorate communities
• Academic Health Science Networks with a tripartite mission and
significant infrastructure investment
• a commitment to linking information from medical and non-
medical sources using electronic patient records to support better
treatment, safety and research
• a new pathway for the regulation and governance of health
research
• collaborative arrangements with the biotechnology
pharmaceutical and medical devices industries
• positioning Scotland as a single research site
44. Health Science Scotland
Health Science Scotland
Executive structure
Health Science Scotland Oversight Board
Chair - Chief Medical Officer
Scottish Government, CEO Health Boards, Vice Chancellors
Health Science Scotland Executive
Convenor – Chief Scientist
Chief Scientist Office, Medical Deans, NHS R&D Directors
Health Science Scotland Central Portal
Programme management, Communications
Recognising the need for critical mass in academic excellence and healthcare systems to compete as
a global destination for medical research the Collaboration was formed in 2005.
45. Key Delivery Units
NHS Research Scotland
Clinical Research
Facilities
Tissue acquisition „Safe Havens‟
service Health informatics
Biorepositories research
Project management Research imaging
Quality & Facilitation platform
46. NRS Infrastructure investment
Core research dedicated staff in NHS
188 WTE staff
WTE
86 WTE staff CRF nurses/admin 63
Biorepository 29
Research Imaging 26
Informatics Research 16
Quality/ Governance 22
Clinical trials support 33
2009/10 2010/11 2011/12
£4.5m £10m
Central functions 6.5 WTE manager + admin staff
NRS PCC, databases, contracts, research passport
47. Clinical Research Centres
• State of the art clinical research facilities
• Part of a managed network across Scotland
• All have generic research nurse teams
• All have specialised staff with specific clinical
and technical skills
48. Biorepository network
Strategic national collections
• Rheumatoid arthritis
• Renal cancer
• Type 1 diabetes
• Generation Scotland/ SHHS
National/ local planned collections NRS NE
• Generic consent
• Strategy driven
NRS E
• Future focus
Bespoke collections NRS W
NRS SE
• Specific consent
• Project based Infrastructure development
• Inventory management system
• Investigator „owned‟ • Patient record linkage
• Enhanced storage capacity
Pathology archive • Facilitated rapid access
~200,000 consented for genomic studies
49. Informatics
Information from cradle to
grave...
• Mothers ante-natal records
• Maternity
• Neonatal record
• Register birth - NHS number
• Register with GP - CHI
• GP systems
• Dental Appointments
• Outpatients
• A&E attendance
• General hospital admission
(ICD10/OPCS4)
• Prescribing – community pharmacies
• Cancer registration
• Cancer treatment
• Community care
• Death
50. Health Informatics Centres
NHS Data stores
SAFE HAVEN
Storage Area Network Prescribing
Mortality
(GROS)
Secure storage Hospital episodes
power protection (SMR: ISD)
camera surveillance
Identification
(CHI)
Integrated datasets
laboratory
phenotype
(SCI store)
Imaging
phenotype
(PACS)
Dumb terminals NHS staff
Primary Care?
Accredited academic staff
51. 320-MDCT 3T MRI 128-mCT/PET Cyclotron
SINAPSE “calibrain” The scanner harmonisation problem
• Each scanner presents a unique bias
• Harmonising pre-processing approach
52. Reducing Regulatory Burden
Single sign off across Scotland
NRS Permissions CC
- Approvals NRS
- Costing CC
- Contracting NRS NE
- Reciprocity with NIHR CSP
Regional working – 4 hubs NRS E
- ethics
- R&D management
NRS W NRS SE
Targets
- Ethics approval in 30 days (Scottish average)
- R&D 95% approved in 30days
Universities umbrella agreement of single contracting
53. NRS Permissions Co-ordinating Centre
Performance
Table 1 Time (working days) to approval for multi-site studies
Time to permission for all Scottish sites
Non-commercial Commercial
Notes :
Time to permission is the number of working days elapsed between the receipt of a „full document set‟ by the Permissions
Centre and management approval by all Scottish sites. It includes the time taken for generic review of principal governance
issues by the lead review site (once for Scotland) and for local review of resource availability.
54. Case Studies
Trials
Evaluation of policy
Genetics
National programmes
Exporting the Model
55. Informatics Driving Efficiency in Clinical Trials
• Scottish Diabetes Research Network
• National collaboration for clinical trials
• Research register of patients
– On personal approach, 70% of patients agree
to join the register.
– By invitation letter from GP, 50% of patients
agree to join.
• Major programmes from EU (SUMMIT
€24M), Innovative Medicines Initiative
(DIRECT €22M), JDRF (£3,5M)
• www.sdrn.org.uk
56.
57. Research Criteria
Welcome: Emma Riches
Patient Specific Criteria
Please complete the form below in order to generate a list
of people with diabetes who meet the specified criteria of
the study;
People with Diabetes Type =
Age Criteria:
Biochemistry Criteria
Blood Pressure:
BMI:
Cholesterol:
Creatinine:
HbA1c:
The above values need to be recorded within the;
Submit Reset
Please Select Diabetes Type Drop down options;
Type 1
Type2
Both Type 1 & 2
Please Select Drop down for BP/ BMI/ Cholesterol/ Creatinine/ HbA1c;
58. Case Study
• Phase III NCE cardiovascular outcomes trial.
• target recruitment 10 patients in 18 months.
• 10 patients contacted from research
register, all 10 screened and randomised.
• Site hit target in < 2 weeks and was global
top recruiter for 3 months.
60. Efficient trial follow up
West of Scotland Coronary Prevention
Study
Placebo
CHD related death or MI
Log-rank p=<0.0001
Pravastatin
Original trial
Ford et al, N Eng J Med (2007) 357 1477-86
61.
62. Case Studies
Trials
Evaluation of policy
Genetics
National programmes
Exporting the Model
63. Non-experimental evaluation (policy)
Effect of smoking legislation in Scotland
Admissions fell by 17% - 67% of
reduction was in non-smokers Before ban 5.2% increase per annum
Fall in England 4% (no legislation); After ban 18.2% decrease per annum
long term trend 3%
Acute Coronary syndrome Childhood asthma
Pell et al, N Eng J Med (2008) 359; 482-491 Pell et al New Engl J M 201o, 363 . pp. 1139-1145
64. Case Studies
Trials
Evaluation of policy
Genetics
National programmes
Exporting the Model
65. The population model
Scotland Phenotyped
cohorts Genetic Epidemiology
Translational Programmes
Epidemiology & Trials
66. “The outstanding longitudinal tracking
you have in place will add
considerable information …….there
is no doubt that a resource like this is
desperately needed.”
David Altshuler
Department of Genetics, Harvard Medical School;Department of
Medicine, Massachusetts General Hospital
67. GENETICS - ADDING VALUE TO RESEARCH:
BIOBANKING PROGRAMMES
• Generation Scotland
• Scotland wide
• >30,000
• UK Biobank
• 50,000 Scots recruited
• Exemplar of informatics linkage
• Colon cancer
• Cardiovascular disease
• Type 2 Diabetes
• >20,000
• DNA distributed nationally
• Type 1 Diabetes
• Scotland wide
• 10,000
69. Illustration of the power of genetics
Studies in twins separated at birth
Dizygotic
Twins
Monozygotic
Twins
Borjeson,Acta Paed.1976
70. Is it worth studying genetics of chronic
diseases?
Diabetes life time risk
0 Parent 10%
1 Parent 30%
Brother/sister 40%
Both parents 70%
Identical twin 80-100 %
Can molecular genetics define pathophysiology?
72. Until.....the march of technology!!
single variant
(100 SNPs; 103 genotypes)
detailed study of individual genes
(102 SNPs; 105+ genotypes)
regional studies
(104 SNPs; 108 genotypes )
genome-wide association
(106 SNPs; 1010 genotypes)
complete resequencing
(108 SNPs / 1012 genotypes)
73. Map of diabetes susceptibility June 2012
Effect
size PNDM HNF1A
other
MODY few if any genes
Large TNDM
up here
Other rare
syndromes
mt3243
LMNA
TCF7L2
FTO
PPARG
CDKAL1
IGF2BP2 CDKN2A
LARS2 SLC30A8 KCNJ11
ACDC CAPN10 WFS1 HHEX
HNF4A
Not in my LMNA
INS
Lifetime!
Small Allele
Rare Common frequency
74. Now we have some genes…
Clinical medicine
Genetics:
Do these variants allow us
to predict disease progression
(eg from prediabetes) and the effect of Which are the aetiological variants
lifestyle interventions?
Genetic epidemiology
Confirmed
Cell biology
How does variation here
interact with variation at other
sites? variants
What are the molecular
mechanisms?
Pharmacogenetics
Do these variants also influence
complication risk, or response to
Physiology
What are the physiological correlates
available treatments?
Epidemiology
of these variants?
What is the population risk
and are there important
interactions with exposures?
75. WILL IT HELP PRESCRIBING?
THERE IS CONSIDERABLE VARIATION
IN RESPONSE TO MOST DRUGS
Baseline Hba1c 8-9%
60
50 Mean reduction = 1.315
Std. Dev. = 1.05189
40
N = 290
30
Frequency
20
10
0
-3.00 -2.00 -1.00 0.00 1.00 2.00 3.00 4.00
Absolute HbA1c reduction
Data from DARTS, Tayside, Scotland
76. PHARMACOGENETICS:
• In use for over 50 years
• We still don‟t understand
how it works
• 25% of patients get GI
intolerance;
• 5% cannot continue it
• Can we use genetics to help
us?
• Ability to link genetics with GWAS Metformin Response
Q-Q plot
drug exposure and
therapeutic response
77. The gene links cancer pathways, metformin pathways
and type 2 diabetes
78. Case Studies
Trials
Evaluation of policy
Genetics
National programmes
Exporting the Model
79. National Collaborations
Wyeth 2006-2011
Grand Challenges 2011-2014
Preferred Site
Preferred Site
National Informatics Programme
Scottish Stem Cell Network
Generation Scotland
80. Case Studies
Trials
Evaluation of policy
Genetics
National programmes
Exporting the Model
81. Internationalisation
Kuwait Scotland eHealth
Innovation Network
“The Scottish Health Science
Package”
•Scientific Research
•Education
•Clinical Skills
•Informatics
82. Education
• PG Certificate/Diploma/MSc Diabetes Care & Education
– training the multi-disciplinary health care team
– 120 students enrolled
• Two „Discovery Courses‟ have exposed 400 HCPs in Kuwait
to latest diabetes knowledge (March & May 2011)
• “OSCE” assessments and workshops for Nurse
Educators, Nutritionists, Call centre team
• National Clinical Skills Facility
– 1st of its kind within GCC, modelled on world-class
facility at University of Dundee
– Provides novel and safe training environment for all
HCPs in Kuwait
82
83. KHN Designs: Home page
Service
Improvement
Find patient
quickly
Integrated Community
Learning tools
84. Scotland as a Single Research Site
Challenges for Delivery
“However, access to
clinical data ……is
currently hampered by a
fragmented legal
framework, inconsistency
in interpretation of the
regulations, variable
guidance and a lack of
clarity among
investigators, regulators,
patients and the public”
85. It’s true in Scotland!
Linkage of SCI-DC to SMR 01
• R&D approval from 14 Boards
– 8 page form, covering letter, CV, proposal, sponsor letter,
funder letter
• Ethics approval 23 page form
• PAC approval 11 pages
• 14 Caldicott guardian approvals
– Initially difficult to identify
– Took 4 months to get all replies
– Multiple contacts - 5 requested further information
– “end to end” 16 months
88. Recommendations
• Governance
Infrastructure
• Research Infrastructure
• National Safe Haven
– located in NSS
• Model to be mirrored at
Health Science Scotland
nodes
89. Proportionate Governance
Category 3:
High impact
full review
possible
further
conditions
Category 2: Medium impact
Fast track review – possible
further conditions
Category 1: Low impact
Stage 2 No further review: standard
Stage 1 terms and conditions
Benchmarks Privacy Risk
Assessment
Category 0: Public domain
No further conditions
90. Scotland : A World Leading Global Hub
10 “C‟s for Success”
Clinical quality
Collaboration
Centres of Scientific Excellence
Connectivity across NHS/Universities
Commercial engagement - encouraged
Clinical Trial Permissions/Regulation
Clinical Informatics using the CHI
Clinical Research Facilities
Collections of tissues/DNA
Clinical Research Imaging
91. The Final “C”
Beware!
Complacency -
Competition is Fierce
92. Commissioning Development
Programme
Academic Health Science
Networks
May 2012
Building choice of high quality support for commissioners
93. US is doing it!
http://catalyst.harvard.edu/home.html
It is a shared enterprise of Harvard University, its ten schools and its eighteen Academic
Healthcare Centers (AHC), as well as the Boston College School of Nursing, MIT, the
Cambridge Health Alliance, Harvard Pilgrim Health Care and numerous community partners.
Harvard Catalyst was founded in May 2008 with a five year, $117.5 million grant from the
National Institutes of Health (Clinical and Translational Science Center, CTSC) and $75 million
dollars from the Harvard University Science and Engineering Committee, Harvard Medical
School, Harvard School of Public Health, Beth Israel Deaconess Medical Center, Brigham and
Women's Hospital, Children's Hospital Boston, Dana-Farber Cancer Institute and
Massachusetts General Hospital. The resources of the Harvard Catalyst are available to all
faculties at Harvard regardless of their institutional affiliation or academic degree.
94.
95. Centre for innovation Platform
Collaborators
DOBLIN
PLATFORMS
Prediction & Destination Culture &
Mayo Clinic Wellness
Prevention Mayo Clinic Competency
Connection Experience
Experience Experience of Innovation
95
96. Summary
• Opportunities for Scotland to be world leading
despite the current challenges and economic climate
• Open innovation, embedded within NHS Boards a
founding principle
• Bring information science into the Board room
• Could a more collaborative model between NHS and
HEI partners add value?
• Support Scotland‟s first National Outcome
We live in a Scotland that is the most attractive place
for doing business in Europe
97. The road ahead for the next few
years
“The only place where success
comes before work is in a dictionary”
V Sassoon, 1928-2012
“If we do not succeed,
then we run the risk of failure”
D Quayle, 1947- US Vice President
98. "In the
middle of
difficulty
lies
opportunity."
Chronic diseases are the leading cause of mortality in the world, accounting for 36 million deaths in 2008 – 63% of the total global deaths, and more than all other diseases combined. Over a quarter of all patients who die from chronic diseases are under the age of 60. The leading causes of deaths are cardiovascular disease, cancer, chronic respiratory disease and diabetes. The World Health Organisation has warned that the number of deaths from these diseases will increase by 15% between 2010 and 2020 (to 44 million deaths,reaching 52 million by 2030] and by over 20% in some parts of the world such as Africa, South East Asia and the Middle East.Chronic diseases can be attributed to a combination of genetic, environmental and lifestyle factors. Many chronic diseases are caused by preventable and modifiable factors, such as smoking, insufficient physical activity, excess alcohol use, and unhealthy diet. An ageing population and economic influence on lifestyle choices in developing countries has resulted in increased prevalence of chronic diseases.Up to three quarters of people over 75 years of age currently suffer from a chronic disease It is estimated that the incidence of chronic disease in the over 65s will double by 2030 WHO data show that 75% of the population has one chronic disease and 50% have two or more conditions.
for linkage of data from diabetes registers collected in each Health Board in Scotland stored on a central server to other health records including mortality linked Scottish Morbidity Records held by ISDACaDMe = acute episodes, cancer, deaths, mental health
Benchmarks: public interest, safe people, safe systems, safe environment, relative risks.Privacy risk assessment: based on criteria such as disclosiveness, sensitivity etc.