Guidelines and Guideline Development

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

3
Reading

• 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) Recommendations for Guidelines The
  Explicit Approach, JAMA, No.263, pp.2239-2240,
  2243

4
Guidelines

• Purpose
• 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
• Estimation of the effects of practice on outcomes
  important to patients
• Comparison of the outcomes of the practice to
  determine whether
• Benefits outweigh harms
• Health outcomes are worth its costs

5
Seven Tasks of Guideline

• Identify important health outcomes
• Analyze evidence for the effects of the practice
  on those outcomes
• Estimate the magnitudes of the outcomes (benefits
  and harms)
• Compare benefits and harms
• Estimate the costs
• Compare health outcomes with the costs
• Compare alternative practices to determine which
  deserve priority

6
Guideline DevelopmentTraditional approach

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

7
Guideline DevelopmentGlobal Subjective Judgment

• 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
• Expert panels
• No analysis of evidence, no estimation of effect,
  no assessment or description of patient
  preferences, no description of rationale
• Simple, fast, cheap, most accessible

8
Guideline DevelopmentEvidence-Based Guidelines

• Explicit description of available evidence
• No estimate of the magnitudes or compare benefits
  and harms
• 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
• Several months of work and thousands of dollars

9
Guideline DevelopmentOutcomes Based Guidelines

• 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
• Quantitative reasoning can be done subjectively
  or objectively using data for estimation
• Several months and tens of thousands of dollars

10
Guideline DevelopmentPreference based guidelines

• In addition to outcomes based guidelines this
  accommodates patient preferences for outcomes
• May take years and up to millions of dollars

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Important and Required Characteristics

• Accurate available evidence accurately
  reflected
• Accountable might effect thousands of lives,
  therefore all possible questions should be
  answered
• Predictable what would happen to the patient
  when guideline implemented
• 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

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Guidelines Expectations

• Guideline must improve patients lives
• 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

13
Possible objectives in Guideline Development

• Government To control costs
• 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
• Single disease focussed organizations overload
  with narrow guidelines which may not be useful
• Specialist society restricting a role of
  another specialty

14
Guidelines Necessary Components

• Summary of the Guideline
• Background
• Health Problem
• Health and Economic Outcomes
• Evidence
• Effect on Health and Economic Outcomes
• Methods Used to Derive the Estimates of Outcomes
• Preference Judgments
• Instructions on Tailoring Guidelines
• Conflicts with other guidelines
• Comparison with other Interventions
• Caveats
• Authors of the policy

15
Next Session

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