pqcnc sivb ls2 ethics and guideline development: implications for the supporting intended vaginal...

8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative

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Ethics and Guideline Development:

Implications for the Supporting Intended

Vaginal Birth Initiative

Anne Drapkin Lyerly, MD, MAAssociate Professor, Social Medicine

Associate Director, UNC Center for Bioethics

8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative

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Key issues in MOD debates

Cesarean rate Safety Access

8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative

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Cesarean rate

Why be alarmed?

Resource allocation/cost containment

Justice and responsible stewardship

Judgment about the “right” way to deliver

Provider, patient, society – whose view?

Access to preferred delivery mode Practice patterns ↓ low intervention birth

8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative

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Safety

Which risks are reasonable, by whatmeasure, according to whom?

What justifies directive guidelines? Cognitive challenges to risk reasoning

Low risk of very bad outcome

Trade-offs with valued higher probability,often extra-medical outcomes

Weighing maternal and fetal interests

8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative

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Access

Guidelines have potential to constrain

Example: VBA C

1990s – limited access to RCS 2000s – limited access to VBAC

Access to options ≠ autonomy Too many options ↓ autonomy

Availability of certain options to some women

↓ options for others (CDMR)

8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative

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Overview

Four criteria for responsible framework

Safety

Cost-effectiveness

Externalities Preferences

Four types of guidelines

Non-directive

Presumptive

Prescriptive

Restrictive

Three caveats

“scaffolding”

distinctions

8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative

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Guideline development

SafetyCost

Externalities

Preferences

Little et al, Obstet Gynecol 112; 2008

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Safety

Probabilities of medical outcomes

Maternal, neonatal

Short and long term

Value (disvalue) of outcomes RISK → Probability * value

Safety

Beneficence

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Cost-effectiveness

Cost

Cost

Cost of intervention

Cost of sequelae

Effectiveness Function of how outcomes are valued

Justice

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Externalities

Broad clinical and social consequences

Diversion of resources

Shifts in institutional practices Shifts in provider expertise

Shifts in cultural norms

Value

Relevant to the extent they restrict

desired options, set context for decisions

Externalities

Justice

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Preferences

Preferences

Autonomy

Patient-centered considerations

Valuation of discrete outcomes

Valuation of process Comparative valuation

Trade-offs

Not mere preferences

Toothpaste type vs. MOD

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Framework for MOD guidelines

Range of Reasonable Options

Externalities

Safety and efficacy Cost-effectiveness

Little et al, Obstet Gynecol 

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Range of options in birth

Values deeply held

Values varied

Process matters

Range of options inwhich preferences

honored

Birth

Death

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Responsible guideline development

Four criteria for responsible framework Safety

Cost-effectiveness

Externalities

Preferences

Four types of guidelines

Non-directive

Presumptive Prescriptive

Restrictive

Three caveats

“scaffolding”

distinctions

8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative

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Types of guidelines

Non-directive PresumptivePrescriptive

Restrictive

reasonable

optionsdefaults

strongrecommendations limits of 

responsible

practice

Less directive More directive

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How directive?

Strong preferences

Divergent preferences

Importance of choice

Comparable risk, cost

Differential risk

Differential cost*

Non-directive PresumptivePrescriptive

Restrictive

Less directive More directive

Externalities

Autonomy

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Conflation

Non-directive PresumptivePrescriptive

Restrictive

8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative

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Challenges

Aggregation

Central tendency vs. distribution

Population vs. individual patient

Swamping

Discrete outcomes, institutional goals, provider views

“Quixotic quest”

Context

Patient values

Risk elsewhere (clinical, daily life)

8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative

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Conclusions

Responsible guidelines are a function of fourconsiderations

Safety and efficacy, cost-effectiveness, externalities,

patient preferences

Responsible guidelines require understandingand instituting distinctions

Non-directive, presumptive, prescriptive, restrictive

Responsible guidelines require attending tochallenges of risk and value