1. Guidelines and Guideline Development HINF 371 - Medical Methodologies Session 13

2. Objective Understand what are clinical practice guidelines, types of guidelines and characteristics of better guidelines Understand what are clinical practice guidelines, types of guidelines and characteristics of better guidelines

3. Reading Eddy D (1990) Practice Policies: Where do they come from?, JAMA, No.263, pp.1265, 1269, 1272, 1275 Eddy D (1990) Practice Policies: Where do they come from?, JAMA, No.263, pp.1265, 1269, 1272, 1275 Eddy D (1990) Guidelines – How Should They be Designed?, JAMA, No.263, pp.1839-1841 Eddy D (1990) Guidelines – How Should They be Designed?, JAMA, No.263, pp.1839-1841 Eddy D (1990) Recommendations for Guidelines: The Explicit Approach, JAMA, No.263, pp.2239- 2240, 2243 Eddy D (1990) Recommendations for Guidelines: The Explicit Approach, JAMA, No.263, pp.2239- 2240, 2243

4. Guidelines Purpose Purpose To anticipate and simplify decision that would otherwise have to be made on one-by-one basis by individual physicians and their patients. To anticipate and simplify decision that would otherwise have to be made on one-by-one basis by individual physicians and their patients. Guidelines serve the decision making process by Guidelines serve the decision making process by Estimation of the effects of practice on outcomes important to patients Estimation of the effects of practice on outcomes important to patients Comparison of the outcomes of the practice to determine whether Comparison of the outcomes of the practice to determine whether Benefits outweigh harms Benefits outweigh harms Health outcomes are worth its costs Health outcomes are worth its costs

5. Seven Tasks of Guideline 1. Identify important health outcomes 2. Analyze evidence for the effects of the practice on those outcomes 3. Estimate the magnitudes of the outcomes (benefits and harms) 4. Compare benefits and harms 5. Estimate the costs 6. Compare health outcomes with the costs 7. Compare alternative practices to determine which deserve priority

6. Guideline Development Traditional approach Standard and accepted practices Standard and accepted practices They are not designed – they evolve They are not designed – they evolve Invisible Hand – better live and thrive Invisible Hand – better live and thrive Seven tasks are never addressed Seven tasks are never addressed Advantages Advantages Input by thousands of people Input by thousands of people Balanced as average eliminates externalities Balanced as average eliminates externalities Very cheap to develop – in minutes Very cheap to develop – in minutes Disadvantages Disadvantages Enforces the current practice Enforces the current practice Anchored not on reality but on practitioners behaviour Anchored not on reality but on practitioners behaviour Self enforcing cycle that wrong behaviour might be supported Self enforcing cycle that wrong behaviour might be supported

7. Guideline Development Global Subjective Judgment Policy makers subjectively develop a guideline Policy makers subjectively develop a guideline The result of opinions of individuals who attempt to consider all the important factors at once in their heads The result of opinions of individuals who attempt to consider all the important factors at once in their heads Expert panels Expert panels No analysis of evidence, no estimation of effect, no assessment or description of patient preferences, no description of rationale No analysis of evidence, no estimation of effect, no assessment or description of patient preferences, no description of rationale Simple, fast, cheap, most accessible Simple, fast, cheap, most accessible

8. Guideline Development Evidence-Based Guidelines Explicit description of available evidence Explicit description of available evidence No estimate of the magnitudes or compare benefits and harms No estimate of the magnitudes or compare benefits and harms Acknowledges that ‘invisible hand might not work’ and consciously anchors guideline on experimental evidence Acknowledges that ‘invisible hand might not work’ and consciously anchors guideline on experimental evidence Question that it answer: whether the practice under consideration has been shown to be effective in improving the most important outcomes Question that it answer: whether the practice under consideration has been shown to be effective in improving the most important outcomes Several months of work and thousands of dollars Several months of work and thousands of dollars

9. Guideline Development Outcomes Based Guidelines Anchored to the evidence and also explicitly estimates the outcomes of alternative practices Anchored to the evidence and also explicitly estimates the outcomes of alternative practices It is based on quantitative reasoning rather than qualitative in estimating the magnitude of benefits and harms It is based on quantitative reasoning rather than qualitative in estimating the magnitude of benefits and harms Quantitative reasoning can be done subjectively or objectively using data for estimation Quantitative reasoning can be done subjectively or objectively using data for estimation Several months and tens of thousands of dollars Several months and tens of thousands of dollars

10. Guideline Development Preference based guidelines In addition to outcomes based guidelines this accommodates patient preferences for outcomes In addition to outcomes based guidelines this accommodates patient preferences for outcomes May take years and up to millions of dollars May take years and up to millions of dollars

11. Important and Required Characteristics Accurate – available evidence accurately reflected Accurate – available evidence accurately reflected Accountable – might effect thousands of lives, therefore all possible questions should be answered Accountable – might effect thousands of lives, therefore all possible questions should be answered Predictable – what would happen to the patient when guideline implemented Predictable – what would happen to the patient when guideline implemented Defensible – provides information to resolve conflicts – acknowledge the areas of conflict, address these conflicts Defensible – provides information to resolve conflicts – acknowledge the areas of conflict, address these conflicts Usable – can be used in clinical practice with varying patients needs Usable – can be used in clinical practice with varying patients needs

12. Guidelines Expectations Guideline must improve patients’ lives Guideline must improve patients’ lives Guideline must be accepted and applied correctly Guideline must be accepted and applied correctly Guidelines is to modify the behaviour of practitioners to steer their decisions toward actions that the policy makers consider desirable Guidelines is to modify the behaviour of practitioners to steer their decisions toward actions that the policy makers consider desirable

13. Possible objectives in Guideline Development Government – To control costs Government – To control costs Researchers – to make their ideas spread and develop an premature or inappropriately aggressive guideline Researchers – to make their ideas spread and develop an premature or inappropriately aggressive guideline Specialist – to distort the apparent frequencies of diseases and outcomes in order to increase their coverage Specialist – to distort the apparent frequencies of diseases and outcomes in order to increase their coverage Single disease focussed organizations: overload with narrow guidelines which may not be useful Single disease focussed organizations: overload with narrow guidelines which may not be useful Specialist society – restricting a role of another specialty Specialist society – restricting a role of another specialty

14. Guidelines Necessary Components 1. Summary of the Guideline 2. Background 3. Health Problem 4. Health and Economic Outcomes 5. Evidence 6. Effect on Health and Economic Outcomes 7. Methods Used to Derive the Estimates of Outcomes 8. Preference Judgments 9. Instructions on Tailoring Guidelines 10. Conflicts with other guidelines 11. Comparison with other Interventions 12. Caveats 13. Authors of the policy

15. Next Session Pre session – review the selected/given guideline Pre session – review the selected/given guideline Group work Group work Compare selected guidelines to explicit criteria Compare selected guidelines to explicit criteria Compare possible underlying objectives Compare possible underlying objectives Guidelines to work on Guidelines to work on Heart Failure from the BC MoH http://www.health.gov.bc.ca/gpac/pdf/heartfailure.pdf Heart Failure from the BC MoH http://www.health.gov.bc.ca/gpac/pdf/heartfailure.pdf http://www.health.gov.bc.ca/gpac/pdf/heartfailure.pdf Heart failure association of America – review all 16 and focus only on #7 Heart failure association of America – review all 16 and focus only on #7 http://www.heartfailureguideline.org/ http://www.heartfailureguideline.org/ http://www.heartfailureguideline.org/ National Institute for Clinical Evidence National Institute for Clinical Evidence http://guidance.nice.org.uk/CG5/guidance/pdf/English http://guidance.nice.org.uk/CG5/guidance/pdf/English http://guidance.nice.org.uk/CG5/guidance/pdf/English American College of Cardiologists and America Heart Association American College of Cardiologists and America Heart Association http://www.acc.org/qualityandscience/clinical/guidelines/failure/hf_inde x.htm http://www.acc.org/qualityandscience/clinical/guidelines/failure/hf_inde x.htm http://www.acc.org/qualityandscience/clinical/guidelines/failure/hf_inde x.htm http://www.acc.org/qualityandscience/clinical/guidelines/failure/hf_inde x.htm 10 minute presentation for one person from each group regarding their findings 10 minute presentation for one person from each group regarding their findings