Early Goal-Directed Therapy in the Treatment of Severe Sepsis and Septic Shock
2001 · paper · Clinical trials
A randomized trial of six hours of early goal-directed therapy versus standard therapy in 263 emergency department patients with severe sepsis or septic shock. In-hospital mortality was 30.5% with early goal-directed therapy versus 46.5% with standard care.
2 findings
Reference or label Table 1 column headers read "(N=133)" and "(N=130)", but many categorical percentages (e.g. HIV 1.7 / 4.3, alcohol use 38.7, COPD 13.4 / 18.0, septic shock 51.3 / 54.7, antibiotics in first 6 hr 92.4) are reachable only with denominators 119 and 117 (the six-hour completers), while the sex row for early therapy (49.2 / 50.8) fits 130.
- p. 5 Table 1, column headers
(N=133)
- p. 5 Table 1, Human immunodeficiency virus infection row
1.7
- p. 5 Table 1, Sex, Female row
49.2
- p. 7 Table 3, footnote ‡
The denominators indicate the numbers of patients in each group who completed the initial six-hour study period.
Only the authors can say what is right here.
Judge's note: Viewed Table 1 on page 5 and Table 3 on page 7. Reworked the percentages: 2/119=1.68, 46/119=38.66, 16/119=13.45, 110/119=92.44, 5/117=4.27, 21/117=17.95, 61/119=51.26 and 64/117=54.70 all match the printed values, and no integer count over 133 or 130 gives them (e.g. 2/133=1.50, 3/133=2.26; 5/130=3.85, 6/130=4.62). Female 49.2 in the early-therapy column fits 64/130=49.23 but not 57/117 or 58/117. A few rows (CHF 30.2 / 36.7) fit 119/117 only by truncation, so some per-variable missing data may also be involved. Table 1 has no footnote giving a different denominator, and the text says all 263 were in the intention-to-treat analyses; the only mention of 119/117 is Table 3 footnote ‡, which covers causes of death. Only the authors can say which population each row uses.
Second check: another model agreed
Report a problem with this finding
Reference or label Table 1 footnote † ("Values sum to more than 100% because patients could have more than one condition.") is attached to "Diagnosis (%)†", but that block sums to exactly 100% in both columns ("Medical condition 93.3 90.6", "Surgical condition 6.7 9.4").
- p. 5 Table 1, Diagnosis (%)† rows
Medical condition 93.3 90.6
- p. 5 Table 1, Diagnosis (%)† rows
Surgical condition 6.7 9.4
- p. 5 Table 1, footnote †
Values sum to more than 100% because patients could have more than one condition.
Judge's note: Viewed Table 1 on page 5. The dagger is on both "Chronic coexisting conditions (%)†" and "Diagnosis (%)†". The footnote holds for coexisting conditions. In the Diagnosis block, medical plus surgical is 100.0 in each column and the sub-rows add up to their parent rows, so the diagnoses are mutually exclusive and the footnote does not describe them. No number is affected; the dagger on Diagnosis is misapplied.
Second check: another model agreed
Report a problem with this finding
2 minor (typos and the like; most checked by the judge only)
Wording "according to the inclusion18,19 and exclusion criteria (Fig. 1)": Figure 1 shows only the inclusion criteria (SIRS criteria plus systolic blood pressure or lactate); the exclusion criteria appear only in the text.
- p. 3 Eligibility
according to the inclusion 18,19 and exclusion criteria (Fig. 1)
Judge's note: Viewed page 3 and read the Figure 1 content and legend in the page 2 text layer (page 2 image not opened). The figure's top box and legend give the SIRS criteria, blood pressure and lactate thresholds only; no exclusion criteria are shown. The pointer is loose rather than wrong, since the figure does cover enrolment and inclusion, so this is a minor wording point.
Second check: another model agreed
Report a problem with this finding
Wording Discussion: "Among all the patients in the current study in whom the goals with respect to central venous pressure, mean arterial pressure, and urine output during the first six hours were met, 39.8 percent of those assigned to standard therapy were still in this oxygen-dependent phase ... as compared with 5.1 percent"; these are the exact complements of the Results figures ("met by 60.2 percent of the patients in the standard-therapy group, as compared with 94.9 percent"), which are stated for the whole groups and not for the subset meeting the haemodynamic goals (86.1% and 99.2%).
- p. 9 Discussion, left column
Among all the patients in the current study in whom the goals with respect to central venous pressure, mean arterial pressure, and urine output during the first six hours were met, 39.8 percent of those assigned to standard therapy
- p. 6 Results, Vital Signs and Resuscitation End Points
saturation was met by 60.2 percent of the patients in the standard-therapy group, as compared with 94.9 percent of those in the early-therapy group
- p. 6 Results, Vital Signs and Resuscitation End Points
were achieved in 86.1 percent of the standard-therapy group, as compared with 99.2 percent of the early-therapy group
- p. 9 Discussion, left column, paragraph on venous oxygen saturation
urine output during the first six hours were met, 39.8 percent of those assigned to standard therapy were still in this oxygen-dependent phase
Only the authors can say what is right here.
Judge's note: Viewed pages 6 and 9. 100−60.2=39.8 and 100−94.9=5.1, so the Discussion and Results use the same pair of numbers but describe different denominators: the whole group in Results, and the subset meeting the combined haemodynamic goals in the Discussion. In the standard-therapy group that subset is only 86.1% of patients. Nothing in the text reconciles the two descriptions, and the files do not show which one is accurate. This is an ambiguity in how the population is described, not a demonstrably wrong number.
Second check: another model agreed