Research group in Global health: Ethics, economics and culture End-of-life decisions as bedside rationing An ethical analysis of life support restrictions in an Indian neonatal unit Ingrid Miljeteig (MD)*, Kjell Arne Johansson (MD)*, Sadath A Sayeed (MD, JD)**, Ole Frithjof Norheim(MD, PhD)* *University of Bergen, Norway **Harvard Medical School, Harvard University

Research group in Global health: Ethics, economics and culture Background: limit setting in treatment of neonates MACRO LEVEL: Wealthy countries: –Prioritized group. –National guidelines in several countries. In India: –About neonates are born <32 GAW yearly. –Promotion of community based, low cost interventions. –Bedside rationing MICRO LEVEL: In wealthy countries: –Limit setting for neonates at GAW is done to prohibit futile treatment and act in the best interest of the child in Western countries In one Indian NICU: –Limit setting for neonates <32 GAW is done to prioritize scarce resources and to protect the family from economic ruin

Research group in Global health: Ethics, economics and culture Data from fieldwork in an Indian NICU Setting: –Indian non-profit private tertiary institution –Only 13% of the patients pay 100% of their bill –2250 patients admitted in neonatal dept annually Limits: –<28 GAW: no treatment –>32 GAW; all treated –28-32: depends on other medical and non-medical reasons. Resons to withold/withdrawl treatment; –Prospect of intact survival –The family’s willingness to pay and their motivation –The preciousness of the child for the family –Potential harm or benefit for the family –Efficient use of hospital resources –Opportunity to compensate gender discrimination

Research group in Global health: Ethics, economics and culture Aim: Is withholding of life-saving treatment for children born between 28 and 32 GAW acceptable from an ethical perspective?

Research group in Global health: Ethics, economics and culture 1. Statement of the problem and alternative actions/rules 2. What is the evidence concerning the outcomes of the different alternatives? 3. Are there guidelines or legal Acts that regulate the issue at hand? 4. Who are the affected parties? 5. What are the benefits and burdens for the affected parties? 6. Are substantial interests in conflict? 7. Are fundamental principles in conflict ? Method: Seven-step impartial ethical analysis

Research group in Global health: Ethics, economics and culture 1. Statement of the problem and alternative actions/rules Is it ever permissible to withhold or withdraw treatment of neonates >28 and <32 gestational age weeks? A) No, it is never permissible to withhold or withdraw treatment of neonates >28 and <32 gestational age weeks B) Yes it is sometimes permissible to withhold or withdraw treatment of neonates >28 and <32 gestational age weeks

Research group in Global health: Ethics, economics and culture 2. What is the evidence concerning the outcomes of the different alternatives? Methodological considerations Analysis of four accepted priority criteria: severity of disease, treatment effect, cost effectiveness and evidence for neonates born at 28 and 32 GAW Severity of disease; estimates of prognosis without treatment in the two GA groups depends on expert opinions from independent neonatologists Effectiveness; a) survival rate from live births in hospitals that provide neonatal intensive care until discharge, b) and the five-year survival rate from live births at a hospital with neonatal intensive care units (NICU). We estimate the mean effect per child that is admitted to hospital with NICU in QALYs. We apply a health system perspective on costs and include only the expenditures of the first hospital visit. Costs in the model are grounded on a published empirical cost data from 2003 from a large tertiary care hospital in India.

Research group in Global health: Ethics, economics and culture 2. What is the evidence concerning the outcomes of the different alterantives?

Research group in Global health: Ethics, economics and culture QALY estimations and costs

Research group in Global health: Ethics, economics and culture 3.Are there guidelines or legal Acts that regulate the issue at hand? NO There are no national priority guideline or policy for withholding of treatment of neonates in India; the priority setting is done bedside.

Research group in Global health: Ethics, economics and culture 4. Who are the affected parties? 5. What are the benefits and burdens for the affected parties?

Research group in Global health: Ethics, economics and culture 6. Are substantial interests in conflict? Most important: –Child’s benefit of treatment vs. the family’s ongoing and future burden –Child’s benefit of treatment vs. other children in the department’s need of resources

Research group in Global health: Ethics, economics and culture 7. Are fundamental principles in conflict? Maximize health Maximize welfare Reduce inequalities in health outcome Reduce inequalities in welfare Non-discrimination Age- weighting

Research group in Global health: Ethics, economics and culture Different age weightings 1,5 0 Relative weight Age Equality Biological lifespan Prudential lifespan DALY 1 0,5

Research group in Global health: Ethics, economics and culture The ethical analysis sketches out two possibilities: A)It is not ethically permissible to limit treatment to neonates below 32 GAW if assigning high weight to health maximisation and overall health equality; Neonates below 32 GAW score high on severity of disease, efficiency and cost- effectiveness of treatment if one gives full weight to early years of a newborn life. It is in the child’s best interest to be treated. B)It can be considered ethically permissible if high weight is assigned to reducing inequality of welfare and maximising overall welfare and/or not granting full weight to early years of newborns is considered acceptable. From an equity-motivated health and welfare perspective we would not accept B)