BROOKLYN 2 RADIOTHERAPY Carl ROWBOTTOM

1. Sat 31st Aug 2013 Session 2 / Talk 3 11:15 – 12:00 BROOKLYN 2 RADIOTHERAPY Carl ROWBOTTOM ABSTRACT Radiotherapy is part of the care package for 40% of patients cured of their cancer; it is a cost effective and safe form of treatment. This is in large part due to the safety conscious culture embedded within radiotherapy services. When considering innovation the radiotherapy environment can often be negatively seen as a risk-averse culture with clear barriers to progress. The Demings approach to statistical and quality control can be used to ensure quality, improve productivity and introduce innovation safely within a radiotherapy environment. The approach was applied to increasing IMRT provision for patients treated at The Christie, the largest radiotherapy centre in the UK, where levels of IMRT were increased from <5% in 2007 to >35% in 2012. Examples will be given of the use of clear objectives, decision rules, feedback and statistical measurements during the project and continuing in routine practice. It is hoped that repeated application of the principles of the Demings approach will improve the timely uptake of innovations within radiotherapy in the future.

2. Innovation in a safety conscious culture Dr Carl Rowbottom Radiotherapy Physics Group Leader The Christie NHS Foundation Trust, Manchester

3. The Christie One of only 3 specialist cancer hospitals in England One of the largest radiotherapy services in Europe Serves population of 3.2 million people 16 linacs on 3 sites (12:2:2)

4. Innovation and a safety conscious culture? • How do we introduce innovation within the radiotherapy environment? • Resistance to change • Ensuring safety of innovation • Diffusion of innovation theory • Standardization – Edwards Deming systems thinking • Increasing IMRT provision at The Christie as a case study........

5. How can we apply diffusion of innovation theory & systems thinking to improve IMRT provision?

6. Diffusion of Innovations • Everett Rogers describes theory to describe how, why and at what rate new ideas/technology spread through cultures.....

7. Diffusion of Innovations • There are 5 stages in the decision innovation process • Knowledge – individual exposed to an innovation, lacks information about innovation • Persuasion – individual interested in the innovation and seeks information • Decision – Individual weighs advantages/disadvantages of using the innovation • Implementation – Individual employs the innovation to a varying degree • Confirmation – individual finalizes decision to continue using innovation.

8. Diffusion of Innovations • There are strategies to help diffusion...... • Innovation adopted by a highly respected individual within a social network • Create desire for a specific innovation • Find early adopters to use innovation • Provide positive reactions and benefits for early adopters on innovation • Benefits to patients • Benefits to staff

9. Edwards Deming – Systems Thinking • ‘If you can’t describe what you are doing as a process, you don’t know what you are doing.’ • Key ideas • Understand sources of variation, work on consistency • Use statistical process control to distinguish between different types of variability • Perpetuate a cycle of continuous quality improvement

10. Edwards Deming – Systems Thinking

11. Edwards Deming • ‘To discuss bringing in to a more desirable state an organization whose objectives, and the necessary and appropriate limitations and constraints, are really not stated is to take on an impossible task.’ • ‘The aim of leadership is not merely to find and record failures of men, but to remove the causes of failure: to help people to do a better job with less effort.’

12. IMRT expansion as an example of Innovation in a Safety Critical Environment

13. The Vision Establish a comprehensive intensity modulated radiotherapy service at The Christie With the capacity to offer the treatment to all patients who would benefit from this advanced form of radiotherapy

14. Motivation for the Vision Position at The Christie in 2008: Quota for small number of intensity modulated radiotherapy treatments established in 2006 Quotas set to provide a limited service amounting to ~3% of radical treatments (~20-25% would benefit) 100 patients received intensity modulated radiotherapy compared to ~1000 who would benefit. National picture in 2008: 2% of radical patients treated with Intensity Modulated Radiotherapy1 1. Williams MV, Cooper T, Mackay R, Staffurth J, Routsis D, Burnet N. ‘The implementation of intensity-modulated radiotherapy in the UK’, Clinical Oncology, 22;623-628 (2010)

15. IMRT position @ The Christie in 2008 • Local barriers to increased provision • Small numbers each month make it difficult to gain sufficient familiarity in the process • Background knowledge of staff (IMRT not included in any major training scheme). • Other perceived barriers to IMRT • Linac time & resources for patient QA • Patient throughput (cf conformal treatments?) • Oncologist time for outlining • Familiarity with the process/ Lack of confidence

16. Adoption of Innovation Phase • Focus on training initial core team of physicists and planning radiographers to meet future demand (Early adopters) • Concentrated training & development (theoretical & practical) • (Knowledge / Persuasion) • Focus on improved quality of treatment for the patient • (Persuasion / Decision) • Regular feedback to staff regarding progress • (Implementation / Confirmation)

17. Moving forwards • New IMRT planning room established in Jan 2009 • 2 planning radiographers + 2 physicists • Co-ordinating outlining, planning, verification, treatment of IMRT patients only • (early adopters / implementation phase of adoption) • Increasing targets for number of patients per month • Protocols & SOPs for majority of IMRT treatments • (Standardization / Consistency)

18. Moving forwards • Comprehensive training programme for staff (early majority / late majority) • Background teaching • Practice case studies • Supervised learning • (Persuasion stage of adoption for early/late majority) • Quality Management System (QMS) sign-off • (Standardization / Consistency)

19. Early Adopters - IMRT Central The Christie in 2009

20. Perceived barriers to IMRT • Local barriers to increased provision • Small numbers each month make it difficult to gain sufficient familiarity in the process • Background knowledge of staff (IMRT not included in any major training scheme). • Other perceived barriers to IMRT • Linac time & resources for patient QA • Patient throughput (cf conformal treatments?) • Oncologist time for outlining • Familiarity with the process/ Lack of confidence

21. Will patient specific IMRT/VMAT QA limit capacity?

22. Verification will limit IMRT/VMAT Capacity • Eventually >95 verifications per month needed. • >100 in 2013 (120 inverse planned IMRT/VMAT treatment plans in July 2013)

23. Options for verification? • Scale up resources to achieve verification for all inverse planned treatments • Will resources be available? • Could resource be better utilised? • Batch verifications and perform within first 3 days of treatment • What if days 1-3 are incorrect? • Don’t verify all treatment plans • How do we decide what not to verify? • What other measures do we put in place?

24. Edwards Deming • ‘Routine inspection becomes unreliable through boredom and fatigue’

25. I’M Really Tired IMRT

26. Verification: Results outside tolerance • Error Rates (since Jan 2009) • Prostate (414 patients - 2090 beams) • Dose difference issue - 10 beams (0.5%) • Gamma Analysis issue - 14 beams (0.7%) • H&N (707 patients - 5021 beams) • Dose difference issue - 1 beam (0.02%) • Gamma Analysis issue - 4 beams (0.08%) • Number of plans changed due to verification... 2! (from over 1000 patients!)

27. Build quality in to the process • Technical staff tend to advocate for all patients (Standardization) • Oncologists tend to advocate for individual patients (Personalization) • Personalization can interfere with the goals of Standardization

28. Build quality in to the process • Uncertainties affect outcomes.......

29. What approach would you prefer?

30. What would Edwards Deming say? • ‘Quality comes not from inspection, but from improvement of the production process. Inspection, scrap, downgrading, and rework are not corrective action on the process’ • ‘Putting out fires is not improvement of the process’ • ‘Inspection to improve quality is too late, ineffective, and costly’ • ‘What is needed are operational definitions of what is acceptable and what is not’

31. Build quality in to the process • Follow standard methodology for treatment site whenever possible......... • Clinical site protocol • Standard operating procedures • IMRT/VMAT class solutions (with suggestions for modifications when required) • Agreed assessment forms • Checklists (planning + checking) • Operational definitions / plan metrics • Rejection codes

32. Clinical Site Protocols • Clinical site protocols provide basis for clear operational definitions. • Should include • Scanning • Outlining • Dose limits • Roles/Responsibilities • QA • Need to be reviewed after first cohort of patients completed

33. Operational definitions: Initial Class Solution • Clinical site protocols provide basis for a TP class solution • PTVs, OARs and dummy structures • Beam orientations • Inverse plan optimisation parameters • Hints for what to do when class solution doesn’t give a good enough solution for an individual patient Standardised using Pinnacle Scripts Described in quality management system

34. Knowing when to stop – what is good enough? • Why is it important to clearly know when to stop trying to improve the plan? • Efficiency means more patients planned with IMRT for same effort • Reduces variation in acceptable plans • Reduces waste from rejecting plans (often late in the process) • Saves your sanity

35. What approach would you prefer?

36. How do we know when the IMRT/VMAT plan is good enough?

37. Operational definitions: Agreed assessment values (autoforms) • From the class solution create clear assessment values can be automatically generated & quickly evaluated from the TPS • If the plan meets the assessment values and the distribution and DVHs look ‘normal’ then the plan is acceptable.

38. How do we know that the plan is ‘normal’?Plan Metrics

39. A multi-criteria score (MCS) based on distance between adjacent leaf positions, overall area of the field and beam-weight developed to determine good and bad constructions of the intensity modulation in a plan

40. How do we reduce variations?How do we reduce re-work?

41. Operational definitions: Checklists • Useful to reduce common errors produced by the system of work • Limit to less than 10, preferably less than 5. • Wherever possible produce an active rather than passive response. • Used extensively in aviation & surgery (See Gawande’s book for further details)

43. Operational definitions: Recording plan rejections to feed in to improvement cycle • How well do you understand the system? • How well have you been trained? • Do you know whether you are doing a good job? • How do you compare to your peers?

44. The improvement cycle – reducing variation

45. Quality System improvement cycle • Review of clinical site protocol => class solution changes • Clinical Site Protocol • Clinical requirements of the oncologists • Clear definitions of acceptable doses • Review of class solution => operational definition changes • Review of operational definitions => error/rejection code changes • Class Solution • Best starting set of parameters to achieve the clinical site protocol • Tips for adaptation when class solution fails • Errors/Rejection Codes • Agreed list of reasons for rejection • Operational Definitions • Clearly defined Work Instructions • Automated planning/assessment wherever possible • Agreed assessment (pass/fail) • Checklist to reduce common failure modes • Review of errors/rejection codes => operational definitions

46. Does it work in practice? • Have we seen an increase in the number of patients we are able to treat with IMRT? • 100 patients treated with IMRT in 2008 • 339 patients treated with IMRT in 2009 • 569 patients treated with IMRT in 2010 • 865 patients treated with IMRT in 2011 • 1048 patients treated with IMRT in 2012 • ~1200 patients in 2013?

47. Edwards Deming – Systems Thinking

48. Workload & Stressors in Clinical Radiation Oncology Mazur et al (IJROBP, 2012; 83(5):e571-576) used assessed workload in Clinical Oncology using the NASA Task-Load Index (TLX) 173 workload assessments across multi-professional workforce (Overall TLX score <35 low workload; >55 high workload) Found an association between workload & frequency of reported radiotherapy incidents. Typically there are 3-5 stressors per cycle of analysed tasks Interruptions (41.4%), time factors (17%), technical factors (13.6%), teamwork issues (11.6%), patient factors (9%), environmental factors (7.4%)