PMID- 27191961
OWN - NLM
STAT- MEDLINE
DCOM- 20170707
LR  - 20190213
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 11
IP  - 5
DP  - 2016
TI  - Usual Care and Informed Consent in Clinical Trials of Oxygen Management in 
      Extremely Premature Infants.
PG  - e0155005
LID - 10.1371/journal.pone.0155005 [doi]
LID - e0155005
AB  - 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.
FAU - Cortes-Puch, Irene
AU  - Cortes-Puch I
AD  - Critical Care Medicine Department, Clinical Center, National Institutes of 
      Health, 9000 Rockville Pike, Bldg. 10, Room 2C145, Bethesda, Maryland 20892, 
      United States of America.
FAU - Wesley, Robert A
AU  - Wesley RA
AD  - Biostatistics and Clinical Epidemiology Service, Clinical Center, National 
      Institutes of Health, 9000 Rockville Pike, Bldg. 10, Room 2C145, Bethesda, 
      Maryland 20892, United States of America.
FAU - Carome, Michael A
AU  - Carome MA
AD  - Health Research Group, Public Citizen, 1600 20th Street NW, Washington, D.C. 
      20009, United States of America.
FAU - Danner, Robert L
AU  - Danner RL
AD  - Critical Care Medicine Department, Clinical Center, National Institutes of 
      Health, 9000 Rockville Pike, Bldg. 10, Room 2C145, Bethesda, Maryland 20892, 
      United States of America.
FAU - Wolfe, Sidney M
AU  - Wolfe SM
AD  - Health Research Group, Public Citizen, 1600 20th Street NW, Washington, D.C. 
      20009, United States of America.
FAU - Natanson, Charles
AU  - Natanson C
AD  - Critical Care Medicine Department, Clinical Center, National Institutes of 
      Health, 9000 Rockville Pike, Bldg. 10, Room 2C145, Bethesda, Maryland 20892, 
      United States of America.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20160518
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Infant, Extremely Premature
MH  - Infant, Newborn
MH  - Informed Consent By Minors/*standards
MH  - Intensive Care, Neonatal/legislation & jurisprudence/*standards
MH  - Oximetry/*adverse effects/standards
MH  - *Randomized Controlled Trials as Topic
PMC - PMC4871545
COIS- Competing Interests: The authors do not have any conflicts of interest to 
      declare.
EDAT- 2016/05/19 06:00
MHDA- 2017/07/08 06:00
PMCR- 2016/05/18
CRDT- 2016/05/19 06:00
PHST- 2015/09/09 00:00 [received]
PHST- 2016/04/22 00:00 [accepted]
PHST- 2016/05/19 06:00 [entrez]
PHST- 2016/05/19 06:00 [pubmed]
PHST- 2017/07/08 06:00 [medline]
PHST- 2016/05/18 00:00 [pmc-release]
AID - PONE-D-15-38880 [pii]
AID - 10.1371/journal.pone.0155005 [doi]
PST - epublish
SO  - PLoS One. 2016 May 18;11(5):e0155005. doi: 10.1371/journal.pone.0155005. 
      eCollection 2016.