There are errors in the article by Weiss and colleagues (1), which appeared in the May 15, 2015, issue of the Journal. The authors detected inaccuracies resulting from a miscoding error in their original analysis. Patients for whom the resolution of one organ system dysfunction coincided with the development of a new dysfunction in a separate organ system were incorrectly coded as having multiorgan dysfunction syndrome (MODS); these patients should have been classified as having new or progressive MODS (NPMODS).
The article incorrectly states the number and percentage of patients with MODS on the day of severe sepsis recognition as being 380 (67%); the correct figure is 327 (58%). The incorrect number and percentage of patients with NPMODS was listed as 171 (30%); the correct figure is 228 (40%). The correction in coding did not change the number of organ dysfunctions.
These incorrect figures appear in the Measurements and Main Results in the abstract; in addition, the last sentence in that paragraph should list the estimated sample sizes needed to detect a 5–10% absolute risk reduction in outcomes within interventional trials as being between 165 and 1,471 (not 1,437). The percentage of MODS and NPMODS patients is also misstated in the paragraph beginning in the middle column on page 1152; in addition, the paragraph on that page before the Discussion section should read: “Assuming a 50% consent rate, between 165 and 1,471 [not 1,437] patients per group would need to be enrolled across 9–81 [not 79] PICUs. . . .”
Finally, errors appear in Table 4 and Table E5 in the online supplement; both tables are reprinted below; the corrected figures appear in boldface.
Table 4.
Outcomes for Total Cohort and by Age Category
| Total | Age Categories |
P Value* | ||||||
|---|---|---|---|---|---|---|---|---|
| 0–28 d | 29 d to <1 yr | 1 to <5 yr | 5 to <10 yr | 10 to <15 yr | 15 to <18 yr | |||
| Vasoactive-free days, median (IQR) | 23 (12–28) | 20 (5–26) | 21 (1–27) | 25 (19–28) | 26 (20–28) | 25 (16–28) | 22 (12–28) | <0.001 |
| Ventilator-free days, median (IQR) | 16 (0–25) | 14 (0–23) | 4 (0–21) | 19 (2–25) | 22 (7–28) | 16 (0–28) | 16 (1–28) | <0.001 |
| New or progressive MODS† | 228 (40) | 14 (40) | 60 (43) | 51 (38) | 33 (38) | 43 (41) | 27 (44) | 0.94 |
| PICU mortality | 139 (24) | 9 (26) | 43 (31) | 26 (19) | 20 (23) | 26 (25) | 15 (24) | 0.42 |
| Hospital mortality | 145 (25) | 9 (26) | 43 (31) | 28 (21) | 20 (23) | 28 (26) | 17 (27) | 0.54 |
| At least mild disability‡ | 116 (28) | 8 (31) | 29 (30) | 31 (29) | 18 (27) | 16 (21) | 14 (31) | 0.73 |
| At least moderate disability§ | 73 (17) | 5 (19) | 17 (17) | 17 (16) | 13 (19) | 9 (12) | 12 (27) | 0.40 |
| Death or disability|| | 218 (38) | 14 (40) | 60 (43) | 45 (33) | 33 (38) | 37 (35) | 29 (47) | 0.41 |
Definition of abbreviations: IQR = interquartile range; MODS = multiorgan dysfunction syndrome; PICU = pediatric intensive care unit.
Data presented as n (%), unless otherwise noted.
Kruskal-Wallis test or Fisher’s exact test across age categories.
New or progressive MODS was considered starting the day after sepsis recognition.
Any increase in Pediatric Overall Performance Category (POPC) from baseline to hospital discharge in the 422 hospital survivors.
Discharge POPC ≥ 3 and an increase of ≥1 from baseline in the 422 hospital survivors.
Death or at least moderate disability at hospital discharge.
Table E5.
Sample-Size Estimates across Outcomes
| Outcome | Control* (%) | Intervention (%) | Absolute Risk Reduction (%) | Relative Risk Reduction (%) | N per Group | No. PICUs† (1 yr) | No. PICUs† (3 yr) |
|---|---|---|---|---|---|---|---|
| New or progressive MODS | 40 | 35 | 5 | 13 | 1,471 | 245 | 81 |
| 40 | 30 | 10 | 25 | 356 | 59 | 20 | |
| PICU mortality | 24 | 19 | 5 | 21 | 1,059 | 177 | 58 |
| 24 | 14 | 10 | 42 | 241 | 40 | 13 | |
| Hospital mortality | 25 | 20 | 5 | 20 | 1,094 | 182 | 60 |
| 25 | 15 | 10 | 40 | 250 | 42 | 14 | |
| At least mild disability‡ | 28 | 23 | 5 | 18 | 1,192 | 199 | 65 |
| 28 | 18 | 10 | 36 | 277 | 46 | 15 | |
| At least moderate disability§ | 17 | 12 | 5 | 29 | 778 | 130 | 43 |
| 17 | 7 | 10 | 59 | 165 | 28 | 9 | |
| Death or disability|| | 38 | 33 | 5 | 13 | 1,437 | 240 | 79 |
| 38 | 28 | 10 | 26 | 346 | 58 | 19 |
Definition of abbreviations: MODS = multiorgan dysfunction syndrome; PICU = pediatric intensive care unit.
Baseline estimate from SPROUT study.
Number of PICUs required to meet sample size is estimated based on a median of 16 beds per PICU and a median PICU length of stay of 15 days per patient with a 50% consent rate.
Any increase in POPC from baseline to hospital discharge in the 422 hospital survivors.
Discharge POPC ≥ 3 and an increase of at least 1 from baseline in the 422 hospital survivors.
Death or at least moderate disability at hospital discharge.
The authors have reviewed all of their statistical analyses and believe that the coding error does not alter any of the statistical comparisons or conclusions in the article. They apologize for the inconvenience to the readers.
Reference
- 1.Weiss SL, Fitzgerald JC, Pappachan J, Wheeler D, Jaramillo-Bustamante JC, Salloo A, Singhi SC, Erickson S, Roy JA, Bush JL, et al. Sepsis Prevalence, Outcomes, and Therapies (SPROUT) Study Investigators; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Global epidemiology of pediatric severe sepsis: the Sepsis Prevalence, Outcomes, and Therapies study. Am J Respir Crit Care Med. 2015;191:1147–1157. doi: 10.1164/rccm.201412-2323OC. [DOI] [PMC free article] [PubMed] [Google Scholar]
