Journal Article

SUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies

Lantos, John D., Feudtner, Chris

2015

Overview

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.

• Publisher: Blackwell Publishing Ltd,The Hastings Center
• Subject: Babies / Brain Injuries - etiology / Brain Injuries - metabolism / Brain Injuries - prevention & control / Clinical trials / Comparative analysis / Comparative Effectiveness Research - ethics / Comparative Effectiveness Research - methods / Comparative Effectiveness Research - standards / Comparative Effectiveness Research - trends / Consent / Effectiveness / Ethics / Humans / Implementation / Infant, Newborn / Infant, Premature - blood / Infants / Informed consent / Intensive Care, Neonatal - ethics / Intensive Care, Neonatal - methods / Intensive Care, Neonatal - standards / Intubation, Intratracheal / Medical ethics / Medical treatment / Mortality / Neonatology - ethics / Neonatology - methods / Neonatology - standards / Oximetry - ethics / Oximetry - instrumentation / Oximetry - methods / Oxygen / Oxygen - blood / Oxygen - metabolism / Oxygen therapy / Parental Consent - ethics / Pediatrics / Peer review / Positive-Pressure Respiration - ethics / Premature babies / Premature birth / Questions / Randomized Controlled Trials as Topic - ethics / Research Design - standards / Research ethics / Retinopathy of Prematurity - etiology / Retinopathy of Prematurity - prevention & control / Standard of Care - ethics / Surface-Active Agents - administration & dosage / Treatment Outcome / Truth Disclosure - ethics / Uncertainty