Guidelines and Guideline Guidelines and Guideline Development Development

HINF 371 - Medical MethodologiesHINF 371 - Medical MethodologiesSession 13Session 13

Objective Objective

Understand what are clinical Understand what are clinical practice guidelines, types of practice guidelines, types of guidelines and characteristics of guidelines and characteristics of better guidelinesbetter guidelines

ReadingReading

Eddy D (1990) Practice Policies: Where do Eddy D (1990) Practice Policies: Where do they come from?, JAMA, No.263, pp.1265, they come from?, JAMA, No.263, pp.1265, 1269, 1272, 12751269, 1272, 1275

Eddy D (1990) Guidelines – How Should Eddy D (1990) Guidelines – How Should They be Designed?, JAMA, No.263, pp.1839-They be Designed?, JAMA, No.263, pp.1839-1841 1841 

Eddy D (1990) Recommendations for Eddy D (1990) Recommendations for Guidelines: The Explicit Approach, JAMA, Guidelines: The Explicit Approach, JAMA, No.263, pp.2239-2240, 2243No.263, pp.2239-2240, 2243

GuidelinesGuidelines

PurposePurpose To anticipate and simplify decision that To anticipate and simplify decision that

would otherwise have to be made on one-would otherwise have to be made on one-by-one basis by individual physicians and by-one basis by individual physicians and their patients.their patients.

Guidelines serve the decision making Guidelines serve the decision making process by process by Estimation of the effects of practice on Estimation of the effects of practice on

outcomes important to patientsoutcomes important to patients Comparison of the outcomes of the Comparison of the outcomes of the

practice to determine whetherpractice to determine whether Benefits outweigh harmsBenefits outweigh harms Health outcomes are worth its costsHealth outcomes are worth its costs

Seven Tasks of GuidelineSeven Tasks of Guideline

1.1. Identify important health outcomesIdentify important health outcomes2.2. Analyze evidence for the effects of Analyze evidence for the effects of

the practice on those outcomesthe practice on those outcomes3.3. Estimate the magnitudes of the Estimate the magnitudes of the

outcomes (benefits and harms)outcomes (benefits and harms)4.4. Compare benefits and harmsCompare benefits and harms5.5. Estimate the costsEstimate the costs6.6. Compare health outcomes with the Compare health outcomes with the

costscosts7.7. Compare alternative practices to Compare alternative practices to

determine which deserve prioritydetermine which deserve priority

Guideline DevelopmentGuideline DevelopmentTraditional approachTraditional approach

Standard and accepted practicesStandard and accepted practices They are not designed – they evolveThey are not designed – they evolve Invisible Hand – better live and thriveInvisible Hand – better live and thrive Seven tasks are never addressedSeven tasks are never addressed AdvantagesAdvantages

Input by thousands of peopleInput by thousands of people Balanced as average eliminates externalitiesBalanced as average eliminates externalities Very cheap to develop – in minutesVery cheap to develop – in minutes

DisadvantagesDisadvantages Enforces the current practiceEnforces the current practice Anchored not on reality but on practitioners Anchored not on reality but on practitioners

behaviourbehaviour Self enforcing cycle that wrong behaviour might be Self enforcing cycle that wrong behaviour might be

supportedsupported

Guideline DevelopmentGuideline DevelopmentGlobal Subjective JudgmentGlobal Subjective Judgment

Policy makers subjectively develop a Policy makers subjectively develop a guidelineguideline

The result of opinions of individuals The result of opinions of individuals who attempt to consider all the who attempt to consider all the important factors at once in their headsimportant factors at once in their heads

Expert panelsExpert panels No analysis of evidence, no estimation No analysis of evidence, no estimation

of effect, no assessment or description of effect, no assessment or description of patient preferences, no description of patient preferences, no description of rationaleof rationale

Simple, fast, cheap, most accessibleSimple, fast, cheap, most accessible

Guideline DevelopmentGuideline DevelopmentEvidence-Based GuidelinesEvidence-Based Guidelines

Explicit description of available Explicit description of available evidenceevidence

No estimate of the magnitudes or No estimate of the magnitudes or compare benefits and harmscompare benefits and harms

Acknowledges that ‘invisible hand might Acknowledges that ‘invisible hand might not work’ and consciously anchors not work’ and consciously anchors guideline on experimental evidenceguideline on experimental evidence

Question that it answer: whether the Question that it answer: whether the practice under consideration has been practice under consideration has been shown to be effective in improving the shown to be effective in improving the most important outcomesmost important outcomes

Several months of work and thousands Several months of work and thousands of dollarsof dollars

Guideline DevelopmentGuideline DevelopmentOutcomes Based GuidelinesOutcomes Based Guidelines

Anchored to the evidence and also Anchored to the evidence and also explicitly estimates the outcomes of explicitly estimates the outcomes of alternative practicesalternative practices

It is based on quantitative reasoning It is based on quantitative reasoning rather than qualitative in estimating rather than qualitative in estimating the magnitude of benefits and harmsthe magnitude of benefits and harms

Quantitative reasoning can be done Quantitative reasoning can be done subjectively or objectively using data subjectively or objectively using data for estimationfor estimation

Several months and tens of thousands Several months and tens of thousands of dollarsof dollars

Guideline DevelopmentGuideline DevelopmentPreference based guidelinesPreference based guidelines

In addition to outcomes based In addition to outcomes based guidelines this accommodates guidelines this accommodates patient preferences for outcomespatient preferences for outcomes

May take years and up to May take years and up to millions of dollarsmillions of dollars

Important and Required Important and Required CharacteristicsCharacteristics

Accurate – available evidence Accurate – available evidence accurately reflectedaccurately reflected

Accountable – might effect thousands of Accountable – might effect thousands of lives, therefore all possible questions lives, therefore all possible questions should be answeredshould be answered

Predictable – what would happen to the Predictable – what would happen to the patient when guideline implemented patient when guideline implemented

Defensible – provides information to Defensible – provides information to resolve conflicts – acknowledge the resolve conflicts – acknowledge the areas of conflict, address these conflictsareas of conflict, address these conflicts

Usable – can be used in clinical practice Usable – can be used in clinical practice with varying patients needswith varying patients needs

Guidelines Guidelines ExpectationsExpectations

Guideline must improve patients’ Guideline must improve patients’ liveslives

Guideline must be accepted and Guideline must be accepted and applied correctlyapplied correctly

Guidelines is to modify the Guidelines is to modify the behaviour of practitioners to behaviour of practitioners to steer their decisions toward steer their decisions toward actions that the policy makers actions that the policy makers consider desirableconsider desirable

Possible objectives in Possible objectives in Guideline DevelopmentGuideline Development

Government – To control costsGovernment – To control costs Researchers – to make their ideas Researchers – to make their ideas

spread and develop an premature or spread and develop an premature or inappropriately aggressive guidelineinappropriately aggressive guideline

Specialist – to distort the apparent Specialist – to distort the apparent frequencies of diseases and outcomes frequencies of diseases and outcomes in order to increase their coveragein order to increase their coverage

Single disease focussed Single disease focussed organizations: overload with narrow organizations: overload with narrow guidelines which may not be usefulguidelines which may not be useful

Specialist society – restricting a role Specialist society – restricting a role of another specialtyof another specialty

Guidelines Guidelines Necessary ComponentsNecessary Components

1.1. Summary of the GuidelineSummary of the Guideline2.2. BackgroundBackground3.3. Health ProblemHealth Problem4.4. Health and Economic OutcomesHealth and Economic Outcomes5.5. EvidenceEvidence6.6. Effect on Health and Economic OutcomesEffect on Health and Economic Outcomes7.7. Methods Used to Derive the Estimates of Methods Used to Derive the Estimates of

OutcomesOutcomes8.8. Preference JudgmentsPreference Judgments9.9. Instructions on Tailoring GuidelinesInstructions on Tailoring Guidelines10.10. Conflicts with other guidelinesConflicts with other guidelines11.11. Comparison with other InterventionsComparison with other Interventions12.12. CaveatsCaveats13.13. Authors of the policy Authors of the policy

Next SessionNext Session

Pre session – review the selected/given guidelinePre session – review the selected/given guideline Group workGroup work Compare selected guidelines to explicit criteria Compare selected guidelines to explicit criteria Compare possible underlying objectivesCompare possible underlying objectives Guidelines to work onGuidelines to work on

Heart Failure from the BC MoH Heart Failure from the BC MoH http://www.health.gov.bc.ca/gpac/pdf/heartfailure.pdfhttp://www.health.gov.bc.ca/gpac/pdf/heartfailure.pdf

Heart failure association of America – review all 16 and focus Heart failure association of America – review all 16 and focus only on #7only on #7

http://www.heartfailureguideline.org/http://www.heartfailureguideline.org/ National Institute for Clinical EvidenceNational Institute for Clinical Evidence http://guidance.nice.org.uk/CG5/guidance/pdf/Englishhttp://guidance.nice.org.uk/CG5/guidance/pdf/English American College of Cardiologists and America Heart American College of Cardiologists and America Heart

AssociationAssociation http://www.acc.org/qualityandscience/clinical/guidelines/failurehttp://www.acc.org/qualityandscience/clinical/guidelines/failure

/hf_index.htm/hf_index.htm

10 minute presentation for one person from each group 10 minute presentation for one person from each group regarding their findingsregarding their findings