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Usual Care and Informed Consent in Clinical Trials of Oxygen Management in Extremely Premature Infants
Irene Cortés-Puch1, Robert A Wesley2, Michael A Carome3
1Critical Care Medicine Department, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Bldg. 10, Room 2C145, Bethesda, Maryland 20892, United States of America.
Insights
Informed consent for the SUPPORT trial
Area of Science:
- Neonatal medicine and clinical trial ethics.
Background:
- The Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) faced scrutiny regarding the adequacy of its informed consent process.
- Arguments for adequate consent centered on the studied oxygen saturation ranges aligning with common guidelines.
- This study aimed to verify if the oxygen targets in SUPPORT and similar trials reflected usual care practices.
Purpose of the Study:
- To assess the consistency of oxygen saturation target ranges used in the SUPPORT trial and comparable randomized controlled trials (RCTs) with usual care for extremely premature infants.
- To evaluate the accuracy of informed consent disclosures concerning the studied interventions.
Main Methods:
- Conducted a literature search of PubMed, EMBASE, Web of Science, and Scopus for studies on usual care oxygen management in extremely premature infants published since 1990.
- Extracted data on intended and achieved oxygen saturation levels from relevant studies.
- Reviewed 22 SUPPORT consent forms to analyze statements regarding oxygen interventions.
Main Results:
- The high oxygen saturation target range (91-95%) in SUPPORT was consistent with usual care.
- The low oxygen saturation target range (85-89%) was not representative of usual care, which typically paired lower limits (<88%) with higher upper limits (≥92%).
- Targeting the narrow low range in SUPPORT led to significantly lower achieved saturations and increased time below the target, differing from usual care.
Conclusions:
- The SUPPORT trial did not represent comparative effectiveness research of common practices, as the low oxygen range deviated significantly from usual care.
- Adequate informed consent requires clear communication of substantial differences between trial interventions and usual care, including associated risks.
Objective:
The adequacy of informed consent in the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) has been questioned. SUPPORT investigators and publishing editors, heads of government study funding agencies, and many ethicists have argued that informed consent was adequate because the two oxygen saturation target ranges studied fell within a range commonly recommended in guidelines. We sought to determine whether each oxygen target as studied in SUPPORT and four similar randomized controlled trials (RCTs) was consistent with usual care.
Design/Participants/Setting:
PubMed, EMBASE, Web of Science, and Scopus were searched for English articles back to 1990 providing information on usual care oxygen management in extremely premature infants. Data were extracted on intended and achieved oxygen saturation levels as determined by pulse oximetry. Twenty-two SUPPORT consent forms were examined for statements about oxygen interventions.
Results:
While the high oxygen saturation target range (91 to 95%) was consistent with usual care, the low range (85 to 89%) was not used outside of the SUPPORT trial according to surveys and clinical studies of usual care. During usual care, similar lower limits (< 88%) were universally paired with higher upper limits (≥ 92%) and providers skewed achieved oxygen saturations toward the upper-end of these intended ranges. Blinded targeting of a low narrow range resulted in significantly lower achieved oxygen saturations and a doubling of time spent below the lower limit of the intended range compared to usual care practices. The SUPPORT consent forms suggested that the low oxygen saturation arm was a widely practiced subset of usual care.
Conclusions:
SUPPORT does not exemplify comparative effectiveness research studying practices or therapies in common use. Descriptions of major differences between the interventions studied and commonly practiced usual care, as well as potential risks associated with these differences, are essential elements of adequate informed consent.
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