Children's Mercy Hospital, Kansas City, MO, USA.
Semin Fetal Neonatal Med. 2018 Feb;23(1):68-74. doi: 10.1016/j.siny.2017.10.003. Epub 2017 Oct 31.
The SUPPORT study (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments), sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development to evaluate different oxygen saturation targets for extremely premature babies, led to a national controversy that was surprisingly public, intense, and polarizing. This article describes the study design, the study outcomes, and the key issues. I conclude that the controversy was based on two different views of the clinical investigator. One, held by investigators themselves, is that investigators are primarily committed to the patient's well-being. The other sees the investigator as unable to disentangle his conflicting loyalties and as inevitably prioritizing the goals of research over the goals of patient care. I suggest that our current oversight systems overstate the risks of research and understate the risks of idiosyncratic practice variation. A better system would treat the relative risks of these two phenomena as comparable.
SUPPORT 研究(旨在了解治疗结果和风险的预后和偏好的研究)由尤尼斯·肯尼迪·施莱佛国立儿童健康与人类发育研究所主办,旨在评估极低出生体重儿的不同氧饱和度目标,该研究引发了一场全国性的争议,这场争议出乎意料地公开、激烈且两极分化。本文描述了研究设计、研究结果和关键问题。我得出的结论是,争议的根源在于临床研究者的两种不同观点。一种观点,即研究者自己所持有的观点,认为研究者主要致力于患者的福祉。另一种观点则认为,研究者无法理清自己相互冲突的忠诚,并不可避免地将研究目标置于患者护理目标之上。我认为,我们目前的研究监督系统夸大了研究的风险,而低估了个体实践差异的风险。一个更好的系统应该将这两种现象的相对风险视为相当。