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8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 1/19
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
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 2/19
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
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 3/19
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
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 4/19
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
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 5/19
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
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 6/19
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
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 7/19
Guideline development
SafetyCost
Externalities
Preferences
Little et al, Obstet Gynecol 112; 2008
8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 8/19
Safety
Probabilities of medical outcomes
Maternal, neonatal
Short and long term
Value (disvalue) of outcomes RISK → Probability * value
Safety
Beneficence
8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 9/19
Cost-effectiveness
Cost
Cost
Cost of intervention
Cost of sequelae
Effectiveness Function of how outcomes are valued
Justice
8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 10/19
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
8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 11/19
Preferences
Preferences
Autonomy
Patient-centered considerations
Valuation of discrete outcomes
Valuation of process Comparative valuation
Trade-offs
Not mere preferences
Toothpaste type vs. MOD
8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 12/19
Framework for MOD guidelines
Range of Reasonable Options
Externalities
Safety and efficacy Cost-effectiveness
Little et al, Obstet Gynecol
8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 13/19
Range of options in birth
Values deeply held
Values varied
Process matters
Range of options inwhich preferences
honored
Birth
Death
8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 14/19
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
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 15/19
Types of guidelines
Non-directive PresumptivePrescriptive
Restrictive
reasonable
optionsdefaults
strongrecommendations limits of
responsible
practice
Less directive More directive
8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 16/19
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
8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 17/19
Conflation
Non-directive PresumptivePrescriptive
Restrictive
8/6/2019 PQCNC SIVB LS2 Ethics and Guideline Development: Implications for the Supporting Intended Vaginal Birth Initiative
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 18/19
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
http://slidepdf.com/reader/full/pqcnc-sivb-ls2-ethics-and-guideline-development-implications-for-the-supporting 19/19
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