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Interventional Registries

Interventional Registries. The Audit and Research Potential of the BCIS CCAD Registry Peter F Ludman. NO CONFLICT OF INTEREST TO DECLARE. Audit: Background. Clinical Governance The systematic approach to maintaining and improving the quality of patient care in a health system

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Interventional Registries

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  1. Interventional Registries The Audit and Research Potential of the BCIS CCAD Registry Peter F Ludman

  2. NO CONFLICT OF INTEREST TO DECLARE

  3. Audit: Background • Clinical Governance • The systematic approach to maintaining and improving the quality of patient care in a health system • Recognisably high standards of care • Transparent responsibility and accountability for those standards • A constant dynamic of improvement

  4. Clinical Governance • Education and training • continued professional development • Clinical effectiveness • the appropriateness, efficacy, cost effectiveness and safety of different therapies. • Research and development • the application of new research findings into clinical practice and guideline development. • Openness • Poor practice can thrive if it occurs out of the scrutiny of peers, and while openness is important, it must respect appropriate individual patient and practitioner confidentiality. • Risk management • addressing and minimising risks to patients, physicians and organisations. • Clinical audit

  5. Clinical Audit • Greatest potential to assess quality of care • Domains • Structure • Appropriateness • Process • Outcomes

  6. BPEG SCTS British Paediatric Cardiac Association Aim: Harmonise datasets Design medical audit system Based on principles of quality assurance To be used Nationally 6 Specialist Groups CCAD formed May 1996 DoH funding Pilot for 3 years 1999 onwards Funding via NHS IA

  7. Data Collection Spreadsheet • BCIS-CCAD dataset 5.5.6 (113 fields) csv file spec

  8. CCAD Mechanism Hospital 1 encryption Hospital 2 encryption Internet CCAD Server Hospital 3 encryption . . Hospital n encryption

  9. Central Cardiac Audit Database Domains Heart Valve registry

  10. Central Cardiac Audit Database Domains Heart Valve registry

  11. Procedure Specific AnalysisParticipation inCCAD 2009 data: Ludman

  12. CCAD dataUK PCI data in CCAD as % of Reported Totals 2009 data: Ludman As August 2010

  13. CCAD dataUK PCI data in CCAD as % of Reported Totals 2009 data: Ludman As August 2010

  14. % Completeness12 fields required for risk adjusted outcome NWQIP Top score potential = 1200

  15. 2009 2006 2007 2008

  16. Audit Potential • Structure • Appropriateness • Process • Outcome

  17. Audit Potential • Structure • Appropriateness • Process • Outcome

  18. No PPCI Angiography (76) PCI (105) PPCI day PPCI 24/7

  19. No PPCI Angiography (76) PCI (105) PPCI day PPCI 24/7

  20. Audit Potential • Structure • Appropriateness • Process • Outcome

  21. Appropriateness

  22. 2009 data: Ludman Primary PCI - ? Case selection% Cases over 80 (2009 data) % of cases with age over 80 yrs 11.7% Number of PPCI procedures

  23. 2009 data: Ludman Primary PCI - ? Case selection% Cases over 80 (2009 data) % of cases with age over 80 yrs 11.7% Number of PPCI procedures

  24. 2008 data: Ludman Appropriateness Under analysis Accepted as appropriate

  25. 2008 data: Ludman Appropriateness Acute

  26. 2008 data: Ludman Appropriateness

  27. 2008 data: Ludman Appropriateness

  28. 2008 data: Ludman Appropriateness

  29. 2008 data: Ludman Appropriateness

  30. 2008 data: Ludman Appropriateness

  31. 2008 data: Ludman Appropriateness

  32. 2008 data: Ludman Appropriateness • Stable • CCS 0/1 • no non invasive testing • no invasive testing for ischaemia

  33. Audit Potential • Structure • Appropriateness • Process • Outcome

  34. Primary PCI Admitted from the community D1 Admission to Non-PCI centre D2 Direct admission to PCI centre Transfer to PCI centre device

  35. Primary PCIDirect and IHT:Call to Balloon times < 150 min 2009 data: Ludman 75.3% 3 SD 3 SD 2 SD 2 SD % CTB < 150 min Number of Cases

  36. Audit Potential • Structure • Appropriateness • Process • Outcome

  37. 2009 data: Ludman Outcome 2009 *all PPCI (includes shock / ventilation etc)

  38. 2009 data: Ludman Primary PCI (includes shock/vent)30 day ONS tracked Mortality % Mortality at 30 days 6.2% Shock and ventilation INCLUDED Number of PPCI procedures

  39. NWQIP Model 2009 data: Ludman Observed MACCE Predicted MACCE +3 σ +2 σ -2 σ -3 σ

  40. Live view in Lotus Notes emailed reports Annual reports Feedback to units

  41. National PCI Unit

  42. National 60% 35% 0.9% QEB 66% 55% 2.0%

  43. Delays ReportsMonthly

  44. Cumulative FunnelsQuarterly

  45. Audit Research

  46. Audit Research RCT Registry

  47. Randomised Control Trials Strengths Randomisation Ability to test hypotheses Cause and effect conclusions Precise and robust analysis Weakness Focused entry criteria costs limit patient number and FU duration ESC STEMI Guidelines 13% based on RCTs (Tricoci P JAMA 2009;301:831) Euro Heart Survey up to 89% wld be excluded from RCTs (Hordijk_Trion M EHJ 2006;27:671)

  48. Registry • Strengths • Generalised entry • full spectrum including high risk patients included • Population outcomes • Long follow up • Large numbers of patient assessed • Suited to Risk Modelling • Weaknesses • Non randomised • Observational • Hypothesis generating (cause v effect uncertain)

  49. SCAAR scare James S. EuroInt 2009;5:501 ? 32%  Mortality

  50. SCAAR scare James S. EuroInt 2009;5:501

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