1. Quality Standards for Patients Treated by PCI Peter F Ludman

2. NO CONFLICT OF INTEREST TO DECLARE

3. Caution about ‘standards’ Overall Structure for assessing outcomes What are Quality Standards Options for Standards Quality Standards for Patients treated by PCI

4. Caution about ‘standards’ Overall Structure for assessing outcomes What are Quality Standards Options for Standards Quality Standards for Patients treated by PCI

5. Robert Liston 1794-1847

6. Robert Liston 1 st Professor of Surgery UCL 1 st 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”

7. 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

8. 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

10. Target ‘reports’ Inadequate resource  Creativity Patients held in ambulances –clock doesn't start

11. England 2007-08 Time spent in A&E http://www.ic.nhs.uk/statistics-and-data-collections

12. Local Variation in Pattern http://www.ic.nhs.uk/statistics-and-data-collections National pattern Extremes

13. England 2007-08 Time spent in A&E http://www.ic.nhs.uk/statistics-and-data-collections

14. England 2007-08 Time spent in A&E http://www.ic.nhs.uk/statistics-and-data-collections

15. 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

16. 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

17. Caution about ‘standards’ Overall Structure for assessing outcomes What are Quality Standards Options for Standards Quality Standards for Patients treated by PCI

18. Outcome Measurement Hierachy Porter NEJM 2010;363:2477 Tier 1 Health 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 or treatment process Tier 3 Sustainability of health Sustainability of health & nature of recurrences Long term consequences of therapy

19. Outcome Measurement Hierachy Porter NEJM 2010;363:2477 Tier 1 Health 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 or treatment process Tier 3 Sustainability of health Sustainability of health & nature of recurrences Long term consequences of therapy

20. Outcome Measurement Hierachy Porter NEJM 2010;363:2477 Tier 1 Health 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 or treatment process Tier 3 Sustainability of health Sustainability of health & nature of recurrences Long term consequences of therapy

21. Outcome Measurement Hierachy Porter NEJM 2010;363:2477 Tier 1 Health 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 or treatment process Tier 3 Sustainability of health Sustainability of health & nature of recurrences Long term consequences of therapy

22. 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 Maintained freedom from symptoms / need for repeat PCI / staged procedures Long term consequences of therapy Stent thrombosis / drug side effects

23. 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

24. Caution about ‘standards’ Overall Structure for assessing outcomes What are Quality Standards Options for Standards Quality Standards for Patients treated by PCI

25. White Paper July 2010

26. Equity and Excellence: Liberating the NHS

27. Quality Standards

28. 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/

29. National Quality Board Established 2009 Champion quality and ensure alignment in quality throughout NHS ‘Multi-stakeholder’ board

30. National Quality Board

32. NQB Prioritisation Committee Refer topics to NICE NICE topic Expert Group 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 Ministers

33. 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

34. Caution about ‘standards’ Overall Structure for assessing outcomes What are Quality Standards Options for Standards Quality Standards for Patients treated by PCI

35. NICE guidance so far Technology Appraisals –Drug Eluting Stents TA 152 (July 2008) DES if artery 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)

36. NICE guidance so far Technology Appraisals –Drug Eluting Stents TA 152 (July 2008) DES if artery 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 dataset Single lesions only

37. NICE guidance so far Technology Appraisals in Progress –Ticagraor for ACS (July 2011) –Bivalirudin for STEMI (?)

38. 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 Ca 2+  Ix other cause / 64 CT/ angio –30-60%  functional imaging –61-90%  angiography

39. NICE guidance so far Clinical Guidelines (cont) –UA and NSTEMI CG94 (March 2010)

40. NICE guidance so far Clinical Guidelines (cont) –UA and NSTEMI CG94 (March 2010) Grace Score > 3%

41. NICE guidance so far Clinical Guidelines (cont) –UA and NSTEMI CG94 (March 2010) Grace Score > 3% Cath < 96 hrs MDT Consider: 2b-3a / bival

42. NICE Currently limited World literature ESC and AHA Guidelines

43. Stable v ACS Stable angina ↓ Symptoms ACS ↓ Recurrent events ↓ Mortality

44. 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 Maintained freedom from symptoms / need for repeat PCI / staged procedures Long term consequences of therapy Stent thrombosis / drug side effects

45. 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 Maintained freedom from symptoms / need for repeat PCI / staged procedures Long term consequences of therapy Stent thrombosis / drug side effects Stable angina

46. 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 Maintained freedom from symptoms / need for repeat PCI / staged procedures Long term consequences of therapy Stent thrombosis / drug side effects Stable angina Safety and Symptoms Patient Reported Outcome Measures

47. 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 Maintained freedom from symptoms / need for repeat PCI / staged procedures Long term consequences of therapy Stent thrombosis / drug side effects ACS

48. 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 Maintained freedom from symptoms / need for repeat PCI / staged procedures Long term consequences of therapy Stent thrombosis / drug side effects ACS Safety and Process

49. Key Quality Standards Safety –Major Averse Events Risk adjusted

50. Key Quality Standards Safety –Major Averse Events Risk adjusted Elective –Symptoms and Quality of Life ACS (non-STEMI) – Structure / appropriateness / process STEMI –Speed

51. UK MINAP Data McLenachan for NHS Improvement Heart

52. PPCI Delay Mortality % Time delay to presentation / Rx Early presenters High risk Late presenters Low risk

53. 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

54. PPCI Door to Balloon Delay National Registry of Myocardial Infarction n=29,222 McNamara JACC 2006:47;2180 High risk Low risk Anterior DM HR>100 BP<100

55. PPCI Door to Balloon Delay NRMI, n=29,222 Relative Risk per extra 15-Minutes DTB time Compared with DTB of 90 Minutes McNamara JACC 2006:47;2180 adapted by Nalamothu

56. PPCI Door to Balloon Delay NRMI, n=29,222 Relative Risk per extra 15-Minutes DTB time Compared with DTB of 90 Minutes Each 15-minute ↓ Door-to-Balloon time was associated with 6.3 fewer deaths per 1000 patients McNamara JACC 2006:47;2180 adapted by Nalamothu

57. Timings in PPCI Patient delay EMS delay 15 minDTBTransport to PCI centre Onset of STEMI FMC Reperfusion System Delay Terkelsen JAMA 2010;304:763

58. PPCI System Delay Western Denmark 2002-2008 n=6,209 Cum Mortality 30.8% 28.1% 23.3% 15.4% Terkelsen JAMA 2010;304:763

59. 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

60. PPCI Mortality v Pre Hospital Δ Aarhus County Denmark, System delay Sorensen EHJ Dec 2010.1093/eurheartj/ehq437 9316784122 Δ 38 minΔ 74 min

61. PPCI Mortality v Pre Hospital Δ Sorensen EHJ Dec 2010.1093/eurheartj/ehq437

62. All cause Mortality median of 4.3 yr FU 31 v 18% Pre-hospital diagnosis HR after adjustment = 0.68 PPCI Mortality v Pre Hospital Δ Sorensen EHJ Dec 2010.1093/eurheartj/ehq437

63. PPCI Call to Balloon time By Admission Route Median CTB min (+/- IQR) 2009 data: Ludman

64. PPCI Call to Balloon time By Admission Route Median CTB min (+/- IQR) 2009 data: Ludman 73.9% Direct v 26.1% IHT

65. 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

66. The End