The Future of Children, Princeton - Brookings: Providing research and analysis to promote effective policies and programs for children.

Treatment decisions for extremely premature infants involve highly complex medical and ethical issues. However well meaning, the imposition of ostensibly simple rules for decision making—such as those promulgated under the Baby Doe regulations—may only increase the suffering of the infant and the family and the devastating long-term effects of perinatal tragedy.

The following kinds of strategies are recommended to policymakers to help improve ethical decision making in the care of high-risk newborns:

1. Increase support for programs and research needed to augment the scientific basis for treatment decisions.

As discussed above, follow-up programs are particularly important but very difficult to conduct and woefully underfunded. Increased support for clinical trials is needed to increase the recognition and use of therapeutic advances and to reduce the number of patients who receive well-intended "therapies" that, in fact, are ineffective or even harmful. Clinical trials should be considered a critical public health need.

2. Increase the support for programs and research needed to augment the ethical basis for treatment decisions.

Considerable research is needed to define better ways to meet the wants and needs of distraught parents in the perinatal period. We need to develop and evaluate better strategies to inform different parents about their infant's condition and treatment and to involve them in decisions to use unproven methods of treatment. As discussed above, the double standard for consent in clinical practice and research encourages widespread use of unproven therapies without proper testing. This should be recognized as a serious problem, and alternative approaches should be formally evaluated.

3. Address the cost of neonatal intensive care by strategies that will also augment the ethical and scientific quality of neonatal intensive care.

These strategies include more appropriate involvement of parents in treatment decisions, recognition of neonatal intensive care as an investigative therapy for some infants, and identification of neonatal units that achieve exemplary outcomes and research. Serious consideration should be given to funding neonatal intensive care as investigative therapy only for infants born in or transferred to these units. Rather than provide funding for routine clinical use of therapies that have not been shown to be effective in clinical trials, serious consideration should also be given to funding their use only in clinical trials. At least initially, this approach might be politically feasible only for new therapies. However, over the long term, it might be a highly effective method to improve outcome as well as reduce cost.

4. Support efforts to provide better estimates of the cost and value of all major medical programs or interventions relative to the goals of medicine.

As noted above, current hospital accounting systems do not allow an accurate measure of true cost. Better mechanisms to assess cost are crucial to making intelligent choices in funding expensive medical programs. Moreover, considerable research is needed to relate the true costs to the benefits, whether these are expressed in life-years gained, quality-adjusted life-years gained, or a better measure yet to be developed.

5. Promote efforts to define the goals of medicine more clearly at a societal level.

This has been a critical but neglected issue in the current health care debate.^77,78 The proper use of limited public funding for health care will depend on both the value ascribed by society to medical care (relative to other societal goods) and the relative value ascribed to the prevention and treatment of suffering, the prevention and rehabilitation of disability, and the postponement of death. These are crucial issues, of course, for patients of all ages.

A cooperative effort among parents, clinicians, clinical investigators, and policymakers is needed to make full use of strategies like those suggested above. This effort will augment the ethical and scientific quality of treatment decisions for premature infants, decisions that have profound long-term consequences for these infants and their families.