Quality Standards for Patients Treated by PCI Peter F Ludman.

Quality Standards forPatients Treated by PCI

Peter F Ludman

NO CONFLICT OF INTEREST TO DECLARE

• Caution about ‘standards’

• Overall Structure for assessing outcomes

• What are Quality Standards

• Options for Standards

Quality Standards forPatients treated by PCI

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”

• 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’

Robert Liston

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 2007-08Time spent in A&E

http://www.ic.nhs.uk/statistics-and-data-collections

Local Variation in Patternhttp://www.ic.nhs.uk/statistics-and-data-collections

Nationalpattern

Extremes



• 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

Outcome Measurement HierachyPorter NEJM 2010;363:2477

Tier 1Health Status Achieved or

Retained

Survival

Degree of Health or recovery

Tier 2 Process of recovery

Time to recovery and return to normal activity

Disutility of care ortreatment process

Tier 3 Sustainability of health

Sustainability of health &nature of recurrences

Long term consequencesof therapy

Outcome Measurement Hierachy

SurvivalMortality post procedure

Risk adjustment


Functional levelCCS class / QoL measures


Time to referral / to investigation to Rx / to recovery 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


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

White Paper July 2010

Equity and Excellence:Liberating the NHS

Quality Standards

Quality Standards

• 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

http://www.nice.org.uk/guidance/qualitystandards/

National Quality Board

• Established 2009

• Champion quality and ensure alignment in quality throughout NHS

• ‘Multi-stakeholder’ board

National Quality Board

NQBPrioritisationCommittee

Refer topicsto NICE

NICE topicExpert Group

• Draw up draft standards– based on NICE guidance and

– other NHS ‘accredited’ sources

6/52Field testingconsultation

NICE Quality Standards Program Board

NICEGuidance Executive

Published on NICE website

Ministers

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

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)• 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)

BCIS datasetSingle lesions

only

NICE guidance so far

• Technology Appraisals in Progress– Ticagraor for ACS (July 2011)– Bivalirudin for STEMI (?)


• 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


• Clinical Guidelines (cont)– UA and NSTEMI CG94 (March 2010)


• Clinical Guidelines (cont)– UA and NSTEMI CG94 (March 2010) Grace

Score > 3%


• Clinical Guidelines (cont)– UA and NSTEMI CG94 (March 2010) Grace

Score > 3%

Cath < 96 hrsMDTConsider:

2b-3a / bival

NICE

• Currently limited

• World literature

• ESC and AHA Guidelines

Stable v ACS

Stableangina

↓ Symptoms

ACS ↓ Recurrent events↓ Mortality



Risk adjustment








medical errors







Risk adjustment








medical errors





Stable angina



Risk adjustment








medical errors





Stable angina

Safety and Symptoms

Patient Reported Outcome Measures



Risk adjustment








medical errors





ACS



Risk adjustment








medical errors





ACS Safety and Process

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

0102030405060708090

100

2008/2 2008/3 2008/4 2009/1 2009/2 2009/3 2009/4 2010/1

%

Primary PCILysis

McLenachan for NHS Improvement Heart

0

20

40

60

80

100

120

0 1 2 3 4

No Rx

PPCI (120 min delay)

PPCI DelayM

orta

lity

%

Time delay to presentation / Rx

Early presentersHigh risk

Late presentersLow risk

PPCI Symptom to Balloon• PPCI, n=1791

1 year mortality is increased by 7.5%for each 30 minute delay

De Luca Circ 2004;109:1223

PPCI Door to Balloon Delay

• National Registry of Myocardial Infarction• n=29,222

McNamara JACC 2006:47;2180

High risk

Low risk

AnteriorDMHR>100BP<100


• NRMI, n=29,222• Relative Risk per extra 15-Minutes DTB time

Compared with DTB of 90 Minutes

McNamara JACC 2006:47;2180adapted by Nalamothu


• NRMI, n=29,222• Relative Risk per extra 15-Minutes DTB time

Compared with DTB of 90 MinutesEach 15-minute ↓ Door-to-Balloon time

was associated with6.3 fewer deaths per 1000 patients

McNamara JACC 2006:47;2180adapted by Nalamothu

Timings in PPCI

Patient delay

EMS delay

15 min DTBTransport to PCI centre

Onset ofSTEMI

FMC Reperfusion

System Delay

Terkelsen JAMA 2010;304:763

PPCI System Delay• Western Denmark 2002-2008• n=6,209

Cum Mortality30.8%28.1%23.3%15.4%

Terkelsen JAMA 2010;304:763

PPCI Mortality v Pre Hospital Δ

• Aarhus County Denmark• Urban and Rural implementation of Pre Hospital

Diagnosis• System delay

• Pre Hospital Diagnosis: 92 min• No Pre Hospital Diagnosis: 153 min

Sorensen EHJ Dec 2010.1093/eurheartj/ehq437

Δ 1 hour

PPCI Mortality v Pre Hospital Δ

• Aarhus County Denmark, System delaySorensen EHJ Dec 2010.1093/eurheartj/ehq437

93 16784 122Δ 38 min Δ 74 min

PPCI Mortality v Pre Hospital ΔSorensen EHJ Dec 2010.1093/eurheartj/ehq437

All cause Mortalitymedian of 4.3 yr FU

31 v 18%Pre-hospital diagnosis

HR after adjustment = 0.68

PPCI Mortality v Pre Hospital ΔSorensen EHJ Dec 2010.1093/eurheartj/ehq437

PPCI Call to Balloon timeBy Admission Route

106

161

114

0

50

100

150

200

250

Direct IHT ALL

Median CTBmin

(+/- IQR)

2009 data: Ludman

PPCI Call to Balloon timeBy Admission Route

106

161

114

0

50

100

150

200

250

Direct IHT ALL

Median CTBmin

(+/- IQR)

2009 data: Ludman

73.9% Direct v 26.1% IHT

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

Quality Standards for Patients Treated by PCI Peter F Ludman.

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