1. Viewpoint 2: A scientific approach to link effective care measurement with tangible improvement Professor Mike Grocott Professor of Anaesthesia and Critical Care Medicine. Chair, National Emergency Laparotomy Audit Director of the NIAA Health Services Research Centre, Health Services Research Centre RCoA

2. Declaration of interests I am a co-investigator on the EPOCH study

3. Linking audit to quality improvement? Definitions Healthcare problem = emergency laparotomy HQIP Audit = NELA Adding value through linked research projects Conclusions

4. Definitions and context Clinical audit ”…a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change.” NICE 2002

5. Definitions and context Emergency Laparotomy An abdominal surgical procedure performed at short notice to treat life-threatening intra- abdominal conditions e.g. obstruction or perforation of the bowel

6. Definitions and context ELN = Emergency Laparotomy Network NELA = National Emergency Laparotomy Audit EPOCH = Enhanced Perioperative Care for High- Risk Patients (clinical trial)

7. Emergency Laparotomy: 1998-2012 High incidence of adverse outcome Poor supervision Low critical care usage High cost Cook BJA 1998 Ford BJA 2007 Shapter Anaesthesia 2012

8. Emergency Laparotomy: 1998-2012 Symons BJS 2013 2000-2009 n = 367,796

9. Emergency Laparotomy Network (ELN)

10. Saunders BJA 2012

11. ELN results: data collection 37 Hospitals returned data 2 hospitals excluded (< 50% case ascertainment) 35 hospitals > 90% case ascertainment 1853 patients 1941 emergency laparotomies 46 (range 8-184) procedures per hospital Saunders BJA 2012

12. ELN results: outcomes Saunders BJA 2012

13. ELN results: outcomes Saunders BJA 2012

14. ELN results: outcomes Saunders BJA 2012ASA = American Society of Anesthesiologists

15. ELN results: outcomes Saunders BJA 2012

16. ELN results: process measures Consultant Surgeon present (41-100%) Consultant Anaesthetist present (25-100%) Level 3 care (10-88%) Goal-directed fluid therapy (0-63%) Consultant presence decreases out of hours Saunders BJA 2012

18. NELA: overview 2012-13Organisational audit 2013-2015Individual patient audit Wide range of stakeholders (CRG) Web-based data entry (and feedback)

19. NELA: organisational audit December 2012-13 190/191 eligible hospitals Report published May 2014

20. NELA: organisational audit Consultant availability variable 1/5 no dedicated theatre 2/3 no interventional radiology 2/3 no endoscopy Pathways and audit variable

21. NELA: patient audit 191/191 entering patient-level data First 6 months results reflect ELN data

22. NELA: quality improvement Organisational audit Model action plan Sharing best practice Patient audit Local availability of data Software added value e.g. run charts

23. How does audit achieve QI?

24. Effect of data collection “Hawthorne effect” Audit driving QI Ivers Cochrane DSR 2012

25. How does audit achieve QI? Effect of data collection “Hawthorne effect” Audit driving QI Research studies Observational studies Platform for interventional studies Ivers Cochrane DSR 2012

26. Audit and QI Observational vs. interventional studies Confounding Bias Anglemyer Cochrane DSR 2014

27. Enhanced Peri-Operative Care for High-risk patients EPOCH Chief Investigator: Prof Rupert Pearse QI Lead: Prof Carol Peden

28. EPOCH background: emergency laparotomy Emergency Laparotomy Network & HES data ≈ 30,000 cases per year (England and Wales) Overall 25% mortality at 90 days Variation in 30-day mortality (4 to 31%) Variation in delivered care (vs. standards)

29. EPOCH background: enhanced recovery Enhanced Recovery Partnership DoH 2012 Mean length of stay Day of surgery admission Mean length of stay Day of surgery admission

30. EPOCH: objectives Can a quality improvement project to implement a care pathway improve 90-day survival for emergency laparotomy? Integrated ethnographic evaluation Cost-effectiveness of project Long-term impact on mortality (via HQIP-NELA)

31. EPOCH: trial design Stepped wedge randomised cluster trial Data capture via HQIP-NELA web portal Intervention (vs. usual care): Integrated Care Pathway Based on RCS-DoH Recommendations Package of training and support

32. RCTs and Cluster RCTs RCT = randomised controlled trial Minimisation of confounding (randomisation) Minimisation of bias (blinding) A priori analysis plan addressing single question RCT: unit of randomisation = patient Cluster RCT: unit of randomisation = cluster

33. Parallel Group Cluster RCT Brown BMC Med Res Meth 2006 RANDOMISE CONTROL INTERVENTION

34. Stepped Wedge Cluster RCT Brown BMC Med Res Meth 2006

35. EPOCH: trial timelines December 2013 Start-up March 2014 Trial starts April 2014 First cluster ‘activated’ August 2015 Final cluster activated Mid - Sept 2015 Final patient recruited

36. EPOCH: patients Aged ≥40 years undergoing non-elective open abdominal surgery in acute NHS hospitals Exclusions: Gynaecological and trauma laparotomy, Repeat laparotomy, Appendicectomy

37. EPOCH: integrated care pathway Visits by QI experts Local champions Local & cluster level multidisciplinary meetings Web resources Local review of local data

38. EPOCH: integrated care pathway Visits by QI experts Local champions Local & cluster level multidisciplinary meetings Web resources Local review of local data Comparator = usual care

39. EPOCH: outcome measures Primary: 90 day mortality Secondary: Hospital stay Hospital re-admission 180 day mortality Cost effectiveness

40. EPOCH: sample size 98 NHS hospitals in 15 regional clusters 27,540 patients 90% power: 25 to 22% mortality reduction Fixed 85 week intervention period Potential to recruit every eligible patient

41. NELA-EPOCH: learning points Risk of confusion over aims of distinct projects Risk of internal conflicts of interest/roles Risk of brand confusion and disengagement EPOCH will distort the results of NELA NELA will distort the results of EPOCH

42. NELA-EPOCH: learning points QI agenda gives the audit more “meaning” EPOCH evaluates QI that NELA may role out Parallel publicity promotes the shared agenda Collaborative team working helps both projects Importance of clearly defined roles

43. Would we do it again? Yes Better wait for the results!

44. Linking audit to quality improvement? Audit alone can improve quality Audit plus focussed QI offers greater improvement National audits offer an economical and efficient platform for clinical trials Research informs standards and guidelines The combination may increase the rate of quality improvement derived from national audits

45. Linking audit to quality improvement? Any questions…?