Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions
Obstetrical & Gynecological Survey, 2007 · paper · Clinical trials
A randomized, double-blind trial of 12,167 women aged 15 to 26 testing a vaccine against four HPV types. In women not previously infected with HPV-16 or HPV-18, it reported 98% efficacy against related high-grade cervical lesions, and 44% in all randomized women.
1 finding
Substance Text: "with the most common event being injection-site pain (risk difference, 6.5 percentage points; 95% CI, 1.4 to 11.7)". In Table 4, 6.5 (1.4 to 11.7) is the figure for any injection-site event; the Pain row gives 7.2 (1.9 to 12.5).
- p. 9 Results, safety paragraph, column 1
event being injection-site pain (risk difference, 6.5 percentage points; 95% CI, 1.4 to 11.7)
- p. 10 Table 4, rows 'Injection-site event' and 'Pain'
7.2 (1.9 to 12.5)
- p. 9 Results, adverse events
injection-site pain (risk difference, 6.5 percentage points; 95% CI, 1.4 to 11.7)
- p. 10 Table 4, Pain row
Pain 372 (83.0) 339 (75.8) 7.2 (1.9 to 12.5)
Judge's note: Page 10 image: in Table 4, the Injection-site event row reads 378 (84.4) vs 348 (77.9), 6.5 (1.4 to 11.7), and the Pain row reads 372 (83.0) vs 339 (75.8), 7.2 (1.9 to 12.5). Page 9 image: the text places 6.5 (1.4 to 11.7) directly after "injection-site pain". The fix is either to attach the figure to the overall injection-site comparison or to cite 7.2 (1.9 to 12.5) for pain.
Second check: another model agreed
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3 minor (typos and the like; most checked by the judge only)
Wording Table 4 footnote *: "The difference in risk is the number in the vaccine group minus the number in the placebo group." The column actually gives differences in percentages.
- p. 10 Table 4, footnote *
The difference in risk is the number in the vaccine group minus the number in the placebo group.
Judge's note: Page 10 image: the column holds percentage-point differences, e.g. 6.5 = 84.4 - 77.9 and not the count difference 378 - 348 = 30. The results text calls them "percentage points". The footnote wording misdescribes the column; the fix is to replace "number" with "percentage".
Second check: another model agreed
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Typo Stray hyphen in Statistical analysis: "For the intention-to-treat-populations, cumulative incidence distributions" (should be "intention-to-treat populations").
- p. 4 Statistical analysis, right column, line 5-6
For the intention-to-treat-populations, cumulative incidence distributions
Judge's note: Page 4 image: the line break falls after "intention-to-", and the next line reads "treat-populations". The hyphen between "treat" and "populations" is therefore printed, not a line-break artefact. Elsewhere the paper writes "intention-to-treat population" with no hyphen. Cosmetic only. The plural may be deliberate, since the paper refers to more than one intention-to-treat analysis.
Second check: none (judge only)
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Typo Discussion: "which the International Federation of Obstetrics and Gynecology classifies as stage 0" puts the words in the reverse order of the organisation's name.
- p. 9 Discussion, first paragraph
International Federation of Obstetrics and Gynecology
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that the official English name of FIGO is "International Federation of Gynecology and Obstetrics". Page 9 image confirms that the printed text reads "International Federation of Obstetrics and Gynecology". Cosmetic only; the meaning is clear.
Second check: none (judge only)