Supplementary Online Content Schmidt B, Whyte RK, Asztalos EV, et al; for the Canadian Oxygen Trial (COT) Group. Effects of targeting higher vs lower arterial oxygen saturations on death or disability in extremely preterm infants: a randomized clinical trial. JAMA. doi:10.1001/jama.2013.5555 etable 1. Duration of study oximetry etable 2. Profiles of true oxygen saturations for all study days with >12 hours of supplemental oxygen efigure 1. Cumulative Mortality in the Two Treatment Groups efigure 2. Comparison of Study Participants Median Arterial Oxygen Saturations in the Canadian Oxygen Trial (COT) and in the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) This supplementary material has been provided by the authors to give readers additional information about their work. 1
etable 1. Duration of Study Oximetry Postmenstrual Age at Oximeter Removal, Median (IQR), wk Duration of Study Oximetry Median (IQR), wk Reason for Discontinuation of Study Oximetry Met oximeter removal 36.1 (36.0-36.4) criteria at 36 weeks n=186 Met oximeter removal 40.0 (40.0-40.3) criteria at 40 weeks 9 Discharged home 38.1 (36.6-39.3) n=101 Died before discharge 27.3 (25.4-30.0) home n=89 Transfer to a non-study 34.1 (33.1-35.6) hospital n=19 Parental consent 32.6 (29.6-35.6) withdrawn Physician request 37.4 (35.3-38.3) n=17 Other reasons 37.6 (37.6-38.9) n=5 All study babies 36.6 (35.9-40.0) n=602 Abbreviation: IQR, interquartile range. 36.0 (36.0-36.3) n=147 40.0 (40.0-40.3) n=184 37.9 (36.4-39.1) n=123 27.0 (25.3-29.6) n=82 35.0 (32.9-37.1) n=21 33.4 (30.7-38.4) 37.5 (37.0-38.4) n=18 37.9 (36.4-38.6) n=8 37.1 (35.9-40.0) n=599 9.6 (8.9-10.6) n=186 14.3 (13.4-15.3) 9 11.9 (10.1-13.3) n=101 1.6 (0.7-3.7) n=89 7.4 (6.9-10.7) n=19 5.5 (3.1-9.9) 11.7 (10.1-12.6) n=17 11.1 (10.9-11.7) n=5 10.7 (8.6-13.6) n=602 9.4 (8.7-10.6) n=147 14.4 (13.3-15.4) n=184 11.1 (9.6-12.9) n=123 1.3 (0.7-3.4) n=82 7.9 (5.7-11.0) n=21 7.9 (4.0-9.9) 11.5 (9.6-12.6) n=18 10.8 (9.9-12.4) n=8 10.9 (8.6-13.7) n=599 2
etable 2. Profiles of True Oxygen Saturations for All Study Days with >12 Hours of Supplemental Oxygen True Oxygen Saturation Profile P Value All Infants b Median saturation (IQR) 90.9% (89.6% to 92.5%) 93.4% (92.7% to 94.2%) <.001 Time spent >98% 2.9% (1.2% to 6.8%) 4.2% (2.1% to 8.2%) <.001 Time spent >95% 16.3% (10.4% to 25.8%) 22.1% (15.4% to 32.0%) <.001 Time spent <85% 19.3% (13.8% to 24.8%) 8.7% (5.7% to 13.3%) <.001 Time spent <80% 7.1% (4.5% to 10.8%) 3.7% (2.1% to 6.5%) <.001 Time spent <70% 1.6% (0.7% to 3.0%) 0.8% (0.4% to 2.0%) <.001 Interaction P-Value a Original oximeter c software Median saturation (IQR) 91.1% (89.8% to 92.8%) 93.5% (92.9% to 94.4%) <.001.68 Time spent >98% 3.0% (1.3% to 6.5%) 4.1% (1.9% to 8.0%).006.30 Time spent >95% 17.5% (10.8% to 26.8%) 22.4% (15.6% to 33.4%) <.001.79 Time spent <85% 20.2% (14.4% to 25.9) 9.1% (5.6% to 12.7%) <.001.11 Time spent <80% 7.2% (4.7% to10.8%) 3.7% (2.0% to 6.1%) <.001.53 Time spent <70% 1.6% (0.8% to 3.1%) 0.8% (0.4% to 2.0%) <.001.86 Revised oximeter d software Median saturation (IQR) 90.6% (89.3% to 92.2%) 93.2% (92.5% to 94.1%) <.001 Time spent >98% 2.8% (1.1% to 7.2%) 4.4% (2.2% to 8.4%) <.001 Time spent >95% 15.2% (9.5% to 25.3%) 21.2% (15.0% to 31.3%) <.001 Time spent <85% 18.5% (12.7% to 24.1%) 8.2% (5.5% to 13.5%) <.001 Time spent <80% 7.2% (4.3% to 10.7%) 3.6% (2.2% to 6.6%) <.001 Time spent <70% 1.7% (0.7% to 3.0%) 0.9% (0.4% to 2.0%) <.001 Abbreviation: IQR, interquartile range. a Original versus revised oximeter software. b Valid saturation data files were submitted to the coordinating center for 1075 infants, 533 infants in the lower saturation target group and 542 infants in the higher saturation target group. c These data are for 258 infants in the lower saturation target group and 251 infants in the higher saturation target group. d These data are for 247 infants in the lower saturation target group and 251 infants in the higher saturation target group. A total of 28 infants in the lower saturation target group and 40 infants in the higher saturation target group were monitored with both versions of the calibration software. 3
efigure 1. Cumulative Mortality in the Two Treatment Groups The numbers of infants who remained at risk are shown at the bottom of the figure in blue color for the lower oxygen saturation target group and in red color for the higher oxygen saturation target group. The P value was determined using an unadjusted Wilcoxon test. 4
efigure 2. Comparison of Study Participants Median Arterial Oxygen Saturations in the Canadian Oxygen Trial (COT) and in the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) The distribution of the individual participants true median arterial saturation is plotted for each treatment group based on all days with more than 12 hours of supplemental oxygen in COT (upper left panel) and while in supplemental oxygen in SUPPORT (lower left panel). The cumulative percentages of infants with median saturations less than or equal to a specified value are plotted for each treatment group in COT (top right panel) and contrasted with SUPPORT (lower right panel). Figure 3 in N Engl J Med 2010;362:1959-69 was the source of all data used to draw the two lower panels. For COT, individual participants median saturations in the upper left panel are grouped in 1 percent intervals and the respective percentages are plotted at the mid-point of the 1 percent interval (e.g. the interval 90.00-90.99% is plotted at 90.50%). In the upper right panel, cumulative percentages of infants are plotted at their exact individual median saturation values. A total of 533 infants in the lower target group and 542 infants in the higher target group contributed adequate saturation data to the COT analysis. The number of study participants who contributed saturation data to Figure 3 of the SUPPORT publication was not explicitly stated. Percentages of infants plotted along the y-axis in the lower left panel differ from those in the original publication because the percentages of infants in each of the SUPPORT treatment groups did not add up to 100 percent. 5