Aspirin in Patients Undergoing Noncardiac Surgery
Journal of Vascular Surgery, 2014 · paper · Clinical trials
A randomized trial of aspirin versus placebo in 10,010 patients having noncardiac surgery. Aspirin did not change the rate of death or nonfatal heart attack at 30 days (7.0% vs 7.1%) but increased major bleeding.
0 findings
None that passed a second check.
6 minor (typos and the like; most checked by the judge only)
Wording The Methods list primary-outcome subgroups as "the aspirin stratum, type of surgery (vascular vs. nonvascular), and the number of criteria of the Revised Cardiac Risk Index", but Figure 2 also shows a "Vascular disease" (No/Yes) subgroup (P for interaction 0.92) that the Methods do not describe.
- p. 4 Statistical Analysis
based on the aspirin stratum, type of surgery (vascular vs. nonvascu-lar), and the number of criteria of the Revised Cardiac Risk Index
- p. 7 Figure 2
Vascular disease
Only the authors can say what is right here.
Judge's note: On page 4 the Methods paragraph names three subgroup variables. The Figure 2 crop on page 7 shows a fourth, vascular disease. The article does not say whether that subgroup was prespecified. The protocol or supplement may cover it, but neither is among the files, so the authors need to clarify.
Second check: another model agreed
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Wording The Methods describe stratum subgroup analyses only "for one of the secondary composite outcomes and for the tertiary outcomes", yet the Results and Discussion report stratum interactions for safety outcomes (stroke P = 0.01, major bleeding, life-threatening or major bleeding) and count "1 of 19 tertiary or safety subgroup analyses".
- p. 4 Statistical Analysis
according to the aspirin stratum, for one of the secondary composite outcomes and for the tertiary out-comes
- p. 5 Results, Differences between Strata
the P val-ue for strata interaction was significant only for stroke (P = 0.01)
- p. 9 Discussion
1 of 19 tertiary or safety subgroup analyses
- p. 4 Statistical Analysis, paragraph 2
for one of the secondary composite outcomes and for the tertiary out-
Only the authors can say what is right here.
Judge's note: Table 2 (page 5 layout text) lists 12 tertiary and 7 safety outcomes, which gives the 19 cited in the Discussion on page 9. The Methods paragraph on page 4 (image checked) does not mention safety outcomes. That leaves unclear whether the stroke interaction came from a prespecified analysis.
Second check: another model agreed
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Typo The Abstract Results print the major-bleeding interval with a stray comma: "95% CI, 1.01, to 1.49".
- p. 1 Abstract, Results
95% CI, 1.01, to 1.49
- p. 1
hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P = 0.04
Judge's note: The page-1 crop shows the comma after 1.01 in print. Table 2 prints 1.23 (1.01–1.49), and the Results and Discussion print "1.01 to 1.49". The numbers agree everywhere, so this is a punctuation slip only.
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Typo In Table 1, the time-from-randomization-to-surgery categories ">24–48 hr" and "≥48 hr" overlap at exactly 48 hr; the last label presumably should read ">48 hr".
- p. 3 Table 1, Time from randomization to surgery
>24–48 hr
- p. 3 Table 1, Time from randomization to surgery
≥48 hr
Judge's note: The page-3 crop confirms both labels as printed. The rows sum to the group totals (aspirin 4998, placebo 5012), so each patient is counted once and only the boundary label is affected.
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Typo Reference 15's erratum citation reads "[Erratum, Lancet 2008; 371:1914l.]" with a stray "l" after the page number.
- p. 10 Reference 15
371:1914l
- p. 10 Reference 15
371:1914l.]
Judge's note: The page-10 crop shows "371:1914l.]" in print. This is a typographic slip in the reference.
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Typo The affiliation prints "Research Institute HCor (Hospital do Coracão)": the c is missing its cedilla (Coração). The tilde is correctly placed, contrary to the reviewer's description.
- p. 10 Affiliations, O.B.
Hospital do Coracão
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the Portuguese spelling 'Coração' in the hospital's name. The page-10 crop shows 'Coracão' with a plain c and ã. The only defect is the missing cedilla on c.
Second check: none (judge only)