Quality Standards for
Patients Treated by PCI
Peter F Ludman
NO CONFLICT OF INTEREST
TO DECLARE
Quality Standards for
Patients treated by PCI
• Caution about ‘standards’
• Overall Structure for assessing
outcomes
• What are Quality Standards
• Options for Standards
Quality Standards for
Patients treated by PCI
• Caution about ‘standards’
• Overall Structure for assessing
outcomes
• What are Quality Standards
• Options for Standards
Robert Liston 1794-1847
Robert Liston
• 1st Professor of Surgery UCL
• 1st Operation under GA in Europe
• Prior to anaesthetics:
– Speed
• ↓ Pain
•  Survival
• Quality = Speed
– “the fastest knife in the West End. He could
amputate a leg in 2 ½ minutes”
Robert Liston
• A High Quality Service?
• Results:
– Amputation 2 ½ minutes
• Patient died from gangrene
– Assistant’s fingers inadvertently cut through
• Assistant died from gangrene
– Cut coat tails of distinguished surgical spectator
• Died of ‘fright’
Trolley waits
• It is unacceptable that some patients have
to wait on trolleys before being admitted to
hospital
• 2000 target
– Trolley wait to < 12 hr
• 2004 target
– Trolley wait < 4 hours
Target ‘reports’
• Inadequate resource  Creativity
• Patients held in ambulances
– clock doesn't start
England 2007-08
Time spent in A&E
http://www.ic.nhs.uk/statistics-and-data-collections
Local Variation in Pattern
http://www.ic.nhs.uk/statistics-and-data-collections
National
pattern
Extremes
England 2007-08
Time spent in A&E
http://www.ic.nhs.uk/statistics-and-data-collections
England 2007-08
Time spent in A&E
http://www.ic.nhs.uk/statistics-and-data-collections
England 2007-08
Time spent in A&E
http://www.ic.nhs.uk/statistics-and-data-collections
• 66% of all patients
are sent to ward in
last 10 min of 4
hours deadline
• ? Correct decision
• ? Correct wards
Measurement of Quality
• Aim
– Highest quality of care for patients
– Outcomes are the true measure of quality
• But
– No single outcome captures results of care
– Measures may be too narrow
• single department / single intervention
• May destabilize care in unmeasured area
– Measures may be too broad
• entire hospital rates of acquired infection
– Measure of process are convenient but surrogates
– Measurement leads to gaming
Quality Standards for
Patients treated by PCI
• Caution about ‘standards’
• Overall Structure for assessing
outcomes
• What are Quality Standards
• Options for Standards
Outcome Measurement Hierachy
Porter NEJM 2010;363:2477
Health Status
Tier 1 Achieved or
Retained
Survival
Degree of Health or recovery
Time to recovery and return to normal
activity
Process of
Tier 2
recovery
Disutility of care or
treatment process
Sustainability of health &
nature of recurrences
Sustainability
Tier 3
of health
Long term consequences
of therapy
Outcome Measurement Hierachy
Porter NEJM 2010;363:2477
Health Status
Tier 1 Achieved or
Retained
Survival
Degree of Health or recovery
Time to recovery and return to normal
activity
Process of
Tier 2
recovery
Disutility of care or
treatment process
Sustainability of health &
nature of recurrences
Sustainability
Tier 3
of health
Long term consequences
of therapy
Outcome Measurement Hierachy
Porter NEJM 2010;363:2477
Health Status
Tier 1 Achieved or
Retained
Survival
Degree of Health or recovery
Time to recovery and return to normal
activity
Process of
Tier 2
recovery
Disutility of care or
treatment process
Sustainability of health &
nature of recurrences
Sustainability
Tier 3
of health
Long term consequences
of therapy
Outcome Measurement Hierachy
Porter NEJM 2010;363:2477
Health Status
Tier 1 Achieved or
Retained
Survival
Degree of Health or recovery
Time to recovery and return to normal
activity
Process of
Tier 2
recovery
Disutility of care or
treatment process
Sustainability of health &
nature of recurrences
Sustainability
Tier 3
of health
Long term consequences
of therapy
Outcome Measurement Hierachy
Survival
Mortality post procedure
Risk adjustment
Degree of Health or
recovery
Functional level
CCS class / QoL measures
Time to recovery and return
to normal activity
Time to referral / to investigation to Rx / to recovery
post Rx / time to return to normal activities / return
to work
Disutility of care or
treatment process
MACCE / delay to emergency Rx / pain / access site
comps / drug side effects / appropriateness of Rx /
medical errors
Sustainability of health &
nature of recurrences
Long term consequences
of therapy
Maintained freedom from symptoms / need for
repeat PCI / staged procedures
Stent thrombosis / drug side effects
Features for Outcome measures
•
•
•
•
Important to patients
Occurrence sufficiently frequent
Features to incorporate entire hierarchy
Practical issues regarding measurement
– Care with measures that encourage gaming
– Objective, standardised and clearly defined
– Methods for gathering data
Quality Standards for
Patients treated by PCI
• Caution about ‘standards’
• Overall Structure for assessing
outcomes
• What are Quality Standards
• Options for Standards
White Paper July 2010
Equity and Excellence:
Liberating the NHS
Quality Standards
Quality Standards
http://www.nice.org.uk/guidance/qualitystandards/
• Specific concise statements that:
– Act as markers of high quality, cost-effective
patient care across a pathway or clinical area
– Derived from best available evidence
– Produced collaboratively with NHS and social
care, with their partners and service users
National Quality Board
• Established 2009
• Champion quality and ensure alignment
in quality throughout NHS
• ‘Multi-stakeholder’ board
National Quality Board
NQB
Prioritisation
Committee
NICE topic
Expert Group
Ministers
Refer topics
to NICE
• Draw up draft standards
– based on NICE guidance and
– other NHS ‘accredited’ sources
6/52
Field testing
consultation
NICE Quality
Standards
Program Board
NICE
Guidance
Executive
Published on
NICE website
Use of Quality Standards
• Patients and Public
– Information regarding the quality of care they can expect to receive
• Clinical staff
– Ensure care provided is based on latest evidence and best practice
• Audit
• Governance
• Professional development and revalidation
• Provider organisations
– A framework for Quality Accounts
– Assess the quality of care being delivered
– Highlight areas for improvement and monitor changes
• Commissioners
– Ensure best care being delivered via contracting process
– Incentive payments (Commissioning for quality improvement CQUIN)
– Demonstration of World Class commissioning competencies
Quality Standards for
Patients treated by PCI
• Caution about ‘standards’
• Overall Structure for assessing
outcomes
• What are Quality Standards
• Options for Standards
NICE guidance so far
• Technology Appraisals
– Drug Eluting Stents TA 152 (July 2008)
• DES if artery < 3 mm diameter or lesion > 15mm long
• Price difference between BEM and DES <= £300
– Prasugrel in ACS TA 182 (Oct 2009)
• Primary PCI
• Stent thrombosis on clopidogrel
• Diabetics with ACS
– MPI TA73 (Nov 2003) partially updated
• Recommended Ix if established CAD and Sx post MI of
after revasc
– Thrombolysis TA52 (Oct 2002)
NICE guidance so far
• Technology Appraisals
– Drug Eluting Stents TA 152 (July 2008)
• DES if artery < 3 mm diameter or lesion > 15mm long
• Price difference between BEM and DES <= £300
– Prasugrel in ACS TA 182 (Oct 2009)
BCIS dataset
• Primary PCI
Single lesions
• Stent thrombosis on clopidogrel
only
• Diabetics with ACS
– MPI TA73 (Nov 2003) partially updated
• Recommended Ix if established CAD and Sx post MI of
after revasc
– Thrombolysis TA52 (Oct 2002)
NICE guidance so far
• Technology Appraisals in Progress
– Ticagraor for ACS (July 2011)
– Bivalirudin for STEMI (?)
NICE guidance so far
• Clinical Guidelines
– Secondary Prevention CG48 (May 2007)
• Life style / Rehab / Medication / Ix / Revasc
– Chest pain recent onset CG95 (March 2010)
• Acute
– Mx based on diagnosis, timing of pain, Tn, ECG
• Stable CAD likelihood
– 10-29%  Coro Ca2+  Ix other cause / 64 CT/ angio
– 30-60%  functional imaging
– 61-90%  angiography
NICE guidance so far
• Clinical Guidelines (cont)
– UA and NSTEMI CG94 (March 2010)
NICE guidance so far
• Clinical Guidelines (cont)
Grace
Score > 3%
– UA and NSTEMI CG94 (March 2010)
NICE guidance so far
• Clinical Guidelines (cont)
Grace
Score > 3%
– UA and NSTEMI CG94 (March 2010)
Cath < 96 hrs
MDT
Consider:
2b-3a / bival
NICE
• Currently limited
• World literature
• ESC and AHA Guidelines
Stable v ACS
Stable
angina
↓ Symptoms
ACS
↓ Recurrent events
↓ Mortality
Outcome Measurement Hierachy
Survival
Mortality post procedure
Risk adjustment
Degree of Health or
recovery
Functional level
CCS class / QoL measures
Time to recovery and return
to normal activity
Time to referral / to investigation to Rx / to recovery
post Rx / time to return to normal activities / return
to work
Disutility of care or
treatment process
MACCE / delay to emergency Rx / pain / access site
comps / drug side effects / appropriateness of Rx /
medical errors
Sustainability of health &
nature of recurrences
Long term consequences
of therapy
Maintained freedom from symptoms / need for
repeat PCI / staged procedures
Stent thrombosis / drug side effects
Outcome Measurement Hierachy
Survival
Mortality post procedure
Risk adjustment
Degree of Health or
recovery
Functional level
CCS class / QoL measures
Time to recovery and return
to normal activity
Time to referral / to investigation to Rx / to recovery
post Rx / time to return to normal activities / return
to work
treatment process
MACCE / delay to emergency Rx / pain / access site
comps / drug side effects / appropriateness of Rx /
medical errors
Stable
angina
Disutility
of care or
Sustainability of health &
nature of recurrences
Long term consequences
of therapy
Maintained freedom from symptoms / need for
repeat PCI / staged procedures
Stent thrombosis / drug side effects
Outcome Measurement Hierachy
Survival
Mortality post procedure
Risk adjustment
Degree of Health or
recovery
Functional level
CCS class / QoL measures
Time to recovery and return
to normal activity
Stable
angina
Disutility
of care or
treatment process
Sustainability of health &
nature of recurrences
Long term consequences
of therapy
Time to referral / to investigation to Rx / to recovery
Safety
and Symptoms
post Rx / time to return to normal activities / return
to work
MACCE / delay to emergency Rx / pain / access site
comps / drug side effects / appropriateness of Rx /
medical errors
Patient Reported
Maintained freedom from
symptoms / need for
Outcome
Measures
repeat PCI / staged procedures
Stent thrombosis / drug side effects
Outcome Measurement Hierachy
Survival
Mortality post procedure
Risk adjustment
Degree of Health or
recovery
Functional level
CCS class / QoL measures
Time to recovery and return
to normal activity
Time to referral / to investigation to Rx / to recovery
post Rx / time to return to normal activities / return
to work
Disutility of care or
treatment process
MACCE / delay to emergency Rx / pain / access site
comps / drug side effects / appropriateness of Rx /
medical errors
Sustainability of health &
nature of recurrences
Long term consequences
of therapy
Maintained freedom from symptoms / need for
repeat PCI / staged procedures
ACS
Stent thrombosis / drug side effects
Outcome Measurement Hierachy
Survival
Mortality post procedure
Risk adjustment
Degree of Health or
recovery
Functional level
CCS class / QoL measures
Time to recovery and return
to normal activity
Time to referral / to investigation to Rx / to recovery
post Rx / time to return to normal activities / return
to work
ACS
Disutility of care or
treatment process
Sustainability of health &
nature of recurrences
Long term consequences
of therapy
Safety
and
Process
MACCE / delay to
emergency
Rx / pain / access site
comps / drug side effects / appropriateness of Rx /
medical errors
Maintained freedom from symptoms / need for
repeat PCI / staged procedures
Stent thrombosis / drug side effects
Key Quality Standards
• Safety
– Major Averse Events
• Risk adjusted
Key Quality Standards
• Safety
– Major Averse Events
• Risk adjusted
• Elective
– Symptoms and Quality of Life
• ACS (non-STEMI)
– Structure / appropriateness / process
• STEMI
– Speed
UK MINAP Data
%
McLenachan for NHS Improvement Heart
100
90
80
70
60
50
40
30
20
10
0
Primary PCI
Lysis
2008/2 2008/3 2008/4 2009/1 2009/2 2009/3 2009/4 2010/1
PPCI Delay
Early presenters
High risk
120
Mortality %
100
Late presenters
Low risk
80
No Rx
PPCI (120 min delay)
60
40
20
0
0
1
2
3
4
Time delay to presentation / Rx
PPCI Symptom to Balloon
• PPCI, n=1791
De Luca Circ 2004;109:1223
1 year mortality is increased by 7.5%
for each 30 minute delay
PPCI Door to Balloon Delay
McNamara JACC 2006:47;2180
• National Registry of Myocardial Infarction
• n=29,222
High risk
Anterior
DM
HR>100
BP<100
Low risk
PPCI Door to Balloon Delay
McNamara JACC 2006:47;2180
adapted by Nalamothu
• NRMI, n=29,222
• Relative Risk per extra 15-Minutes DTB time
Compared with DTB of 90 Minutes
PPCI Door to Balloon Delay
McNamara JACC 2006:47;2180
adapted by Nalamothu
• NRMI, n=29,222
• Relative Each
Risk per
extra 15-Minutes
DTB time
15-minute
↓ Door-to-Balloon
time
Compared with DTB
90 Minuteswith
wasofassociated
6.3 fewer deaths per 1000 patients
Timings in PPCI
Terkelsen JAMA 2010;304:763
Onset of
STEMI
Patient
delay
Reperfusion
FMC
EMS
delay
15 min
Transport to PCI centre
System Delay
DTB
PPCI System Delay
Terkelsen JAMA 2010;304:763
• Western Denmark 2002-2008
• n=6,209
Cum Mortality
30.8%
28.1%
23.3%
15.4%
PPCI Mortality v Pre Hospital Δ
Sorensen EHJ Dec 2010.1093/eurheartj/ehq437
• Aarhus County Denmark
• Urban and Rural implementation of Pre Hospital
Diagnosis
• System delay
• Pre Hospital Diagnosis:
• No Pre Hospital Diagnosis:
Δ 1 hour
92 min
153 min
PPCI Mortality v Pre Hospital Δ
Sorensen EHJ Dec 2010.1093/eurheartj/ehq437
• Aarhus County Denmark, System delay
84
122
Δ 38 min
93
167
Δ 74 min
PPCI Mortality v Pre Hospital Δ
Sorensen EHJ Dec 2010.1093/eurheartj/ehq437
PPCI Mortality v Pre Hospital Δ
Sorensen EHJ Dec 2010.1093/eurheartj/ehq437
All cause Mortality
median of 4.3 yr FU
31 v 18%
Pre-hospital diagnosis
HR after adjustment = 0.68
PPCI Call to Balloon time
By Admission Route
2009 data: Ludman
250
200
Median CTB
min
(+/- IQR)
161
150
100
114
106
50
0
Direct
IHT
ALL
PPCI Call to Balloon time
By Admission Route
2009 data: Ludman
250
73.9% Direct v 26.1% IHT
200
Median CTB
min
(+/- IQR)
161
150
100
114
106
50
0
Direct
IHT
ALL
Conclusion
• Overview of the politics of ‘Quality Standards’
• Clinical governance and quality of patient care is
underpinned by standards
• Not measured  not assessed
• Once measured  inevitable change in its value
• Many hidden traps to what you measure and
how you use it to improve a service
The End