In this issue of The Journal of Medical Ethics, xxx and colleagues report a randomized trial of the influence of default options on delivery room management of an extremely premature infant. They report that among respondents to the hypothetical vignette, those who received the resuscitation default were significantly more likely to choose resuscitation compared with those who were told that the default was comfort care. While the results warrant attention and further investigation, several methodological shortcomings limit the conclusions that can (...) be drawn from this study. (shrink)

The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) has been the focal point of many different criticisms regarding the ethics of the study ever since publication of the trial's findings in 2010 and 2012. In this article, we focus on a concern that the technical design and implementation details of the study were ethically flawed. While the federal Office Human Research Protections focused on the consent form, rather than on the study design and implementation, OHRP's critiques of the consent (...) form reveal views about the study design and implementation that we believe are fundamentally flawed. These criticisms about the design and implementation of SUPPORT, if generalized, become relevant concerns about these aspects of many comparative effectiveness research studies.Our analytical approach will be to use SUPPORT as a prime example of comparative effectiveness research and show why it challenges some prevailing assumptions about the riskiness of research. We will address five aspects of the study design and implementation: 1) randomization, 2) treatment by protocol, 3) choice of endpoints, 4) lack of a “standard care” control group, and 5) the use of altered oximeters. Examining these aspects will allow us to answer two specific central questions. The first is a methodological question with ethical implications: was the study designed in such a way as to answer the primary study question? The second question is whether the study design added or decreased risk to the babies enrolled in the study compared to babies who were not in the study. (shrink)

In “Postponed Withholding: Balanced Decision-Making at the Margins of Viability,” Syltern et al. (2022) propose a novel approach to life-and-death decision making for extremely preterm infants in t...

Counseling parents on the cusp of delivering an extremely preterm infant is performed thousands of times every year in North America, Europe, Japan and in centers situated in other countries around...