Guidelines & Protocols - Prospects & Pitfalls

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Mabel Curtis
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1 Guidelines & Protocols - Prospects & Pitfalls Brian Kavanagh Hospital for Sick Children University of Toronto

2 Conflicts of Interest Patent applied Ventilation Device No financial conflict of interest with the subject matter of this talk

3 Research Support Dr Geoffrey Barker Chair in Critical Care Research 2 Operating Grants - CIHR

4 Questioning Protocols (or Guidelines) upsets People Please: consider the issues, not the controversy

5 Do Protocols Work in Acute Care?

6 6,100 Patients 59 ICUs 19 Protocols per ICU They Don t Help Sevransky et al Crit Care Med, 2015

7 NOT related to protocol compliance Sevransky et al Crit Care Med, 2015

8 Do Protocols Work? Well, SOME must help? BUT: on average, no difference THEN: Some must cause harm QUESTION How could there be harm?

9 ?Correct Attribution

10 Outcomes 1/3 Less Complications Hayes et al N Engl J Med, 2009

11 Implementation of key process measures Hayes et al N Engl J Med, 2009

12 Concordance Did Increased Implementation cause Improved Outcome? If Cause-Effect, anticipate concordance

13 Outcome vs. Implementation Less complications More Implementation More Implementation & Less Complications Hayes et al N Engl J Med, 2009

14 No Concordance, Almost Perfect Discordance No Cause and Effect NOTE: I strongly recommend all the elements of the checklist

15 Attribution matters That s how you know what works (AND what doesn t work) That s how you know what to do (AND, what to avoid) So, misattribution is a problem

16 ?Correct Alignment

17 Basic Training Basic Staffing BCLS Simpler Cases Advanced Training Fellowship Extensive Experience 3 o /4 o Care Poor Performance Excellent Performance Different Problems Need Different Solutions

18 Misalignment #1 Sophisticated Rudimentary Could a protocol developed for a sophisticated context work well in a more rudimentary context?

19 The FEAST Trial Bolus Usual for developed countries Not usual for Sub-Saharan Africa

20 Mortality over 28 Days Bolus No Bolus Maitland et al, NEJM 2011

21 A bundle developed for a sophisticated context might not work well in a more rudimentary setting

22 Misalignment #2 Rudimentary Sophisticated Could a rudimentary bundle impair performance in a more expert setting?

23 Sophisticated ICU: Simple Protocol vs. Complex Protocol Complex Simple Complex Simple Overall Complications ICU Length of Stay Goepfert et al, Anesthesiology 2013

24 A rudimentary protocol may dumb down expertise in CV ICU

25 Misalignment #3 Sophisticated A Sophisticated B Does care that works in one sophisticated context always translate to others?

26 Tight Glucose Control =3.6% Less Deaths =2.6% More Deaths Van den Bergh et al N Engl J Med 2001 NiceSugar Trial N Engl J Med 2001 Not generalizable

27 6,100 Patients Mortality Excess 2.6% NEJM, 2009 Perhaps >5m Patients in ICU in US [SCCM] Perhaps 20% Mechanically Ventilated At least we know the answer IF: TGC caused deaths in 2.6% of patients THEN: -compliance would cause?? deaths -non-compliance would save?? lives

28 Care that works in one sophisticated context may not always translate to others

29 Alignment matters That s lining up the right tools for the right job (AND, setting aside the wrong ones) That s applying the right solution to the problem (AND, avoiding a misfit) So, misalignment is a problem

30 Use of Protocols & Guidelines... AJRCCM 2012

31 When is a Protocol a good Idea? 1. Inherently Simple 2. Explicit Knowledge 3. Minimize Variability

32 Need to Minimize Variability Only one way possible ECMO

33 Need to Minimize Variability Only one way desirable

34 When is a Protocol Not a Good Idea? 1. Too Complex 2. Involves Judgment 3. Tacit Knowledge

35 Tacit Knowledge Difficult to put into words Demands talent Requires practice

36 Protocols & Research Doing Research vs. Applying Research

37 Scientist Clinician William Hamilton ( ) Dominic Corrigan ( ) Discover Knowledge Use Knowledge

38 Research Practice Rigidity Flexibility Why? To know WHAT was done Why? To use ALL your knowledge Point? To gain INSIGHT Point? To best treat THIS patient

39 In research, the protocol must be followed exactly - no flexibility no weasel words [HOWEVER] the insight gained -not the protocol- is the point Tobin MJ, AJRCCM 2004 Needless to say, an expert clinician using the insights derived from a research study, is expected to perform better than relying solely on the study protocol (otherwise their expertise is noncontributory) and, better than they would have before learning the results of the study (otherwise the study insight is noncontributory). Kavanagh & Nurok, AJRCCM 2015

40 WARNING: Protocols & Guidelines Instituted because of lack of staffing or expertise? maybe address the primary problem Admit This? Inform Patients?

41 In medicine some of our most telling lessons come from our mistakes

42 Epilogue Paying for the wrong Protocol The Story of Mr O

43 Sarosi Ann Int Med, 2015

44 Approaches to Minimize Harm 1. Avoid Misattribution 2. Avoid Misalignment 3. Understand Limitations 4. Assess Protocols as a Drug/Device 5. Understand the Need in Research 6. Be Clear about Why it s Needed 7. Don t throw out the Baby

45 Thank You

Physiology to Improve RCTs

Physiology to Improve RCTs Brian Kavanagh Hospital for Sick Children University of Toronto 1 Conflicts of Interest No financial conflict of interest with the subject matter of this talk Where s the Interest