Intensive versus Moderate Lipid Lowering with Statins after Acute Coronary Syndromes
Obstetrics & Gynecology, 2004 · paper · Clinical trials
A trial of 4,162 patients recently hospitalized for acute coronary syndrome, comparing 40 mg pravastatin with 80 mg atorvastatin. Intensive atorvastatin gave lower LDL cholesterol and a 16 percent lower hazard of death or major cardiovascular events.
3 findings
Reference or label Appendix: "Queen Elizabeth Hospital, Woodville, Saskatchewan, Canada: J. Horowitz and R. Prideaux" probably should be Woodville, South Australia.
- p. 9 Appendix, clinical centers enrolling the most patients
Queen Elizabeth Hospital, Woodville, Saskatchewan, Canada: J. Horowitz and R. Prideaux
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the Queen Elizabeth Hospital in Woodville is in South Australia (Adelaide), where J. Horowitz works. The p9 crop shows 'Saskatchewan, Canada' as printed.
Second check: another model agreed
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Reference or label Reference 5 reads "Shepard J, Cobbe SM, Ford I, et al.", while reference 7 reads "Shepherd J, Blauw GJ, Murphy MB, et al."; the WOSCOPS first author is Shepherd.
- p. 10 Reference 5
Shepard J, Cobbe SM, Ford I, et al.
- p. 10 Reference 7
Shepherd J, Blauw GJ, Murphy MB, et al.
- p. 10 Reference 5
Shepard J, Cobbe SM, Ford I
- p. 10 Reference 7
Shepherd J, Blauw GJ
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the WOSCOPS first author is James Shepherd. The p10 crop shows 'Shepard J' in reference 5, and the text layer shows 'Shepherd J' in reference 7.
Second check: another model agreed
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Reference or label Reference 2 reads "Sacks RM, Pfeffer MA, Moye LA, et al."; the CARE first author is Sacks FM.
- p. 10 Reference 2
Sacks RM, Pfeffer MA, Moye LA, et al.
- p. 10 Reference 2
Sacks RM, Pfeffer MA, Moye LA
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the first author of the CARE trial (N Engl J Med 1996;335:1001-9) is Frank M. Sacks. The p10 crop shows 'Sacks RM' as printed.
Second check: another model agreed
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9 minor (typos and the like; most checked by the judge only)
Wording The Abstract says "did not meet the prespecified criterion for equivalence" and the Results say "this difference did not meet the criteria for equivalence", but the Methods prespecify a one-sided noninferiority boundary ("prespecified boundary for noninferiority" ... less than 1.17).
- p. 1 Abstract, Results
did not meet the prespecified criterion for equivalence
- p. 5 Results, primary end point
this difference did not meet the criteria for equivalence
- p. 3 Statistical analysis
prespecified boundary for noninferiority
Judge's note: I viewed the crops for p1 (Abstract), p5 (Results) and p3 (Statistical analysis). The Methods define only a noninferiority criterion: an upper limit of the one-sided 95% CI for the relative risk below 1.17. The Abstract and Results describe the unmet criterion as 'equivalence'. This is a terminology mismatch with the declared analysis. The data are unaffected.
Second check: another model agreed
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Wording "Patients were followed for 18 to 36 months" (also in the Abstract), but enrolment began November 15, 2000 and final visits were in "August or September 2003", so the longest possible follow-up is about 34.5 months.
- p. 3 Methods, study protocol
Patients were followed for 18 to 36 months
- p. 2 Methods, patient population
Between November 15, 2000, and December 22, 2001
- p. 2 Methods, study protocol
until their final visit in August or September 2003
- p. 1 Abstract, Methods
Follow-up lasted 18 to 36 months (mean, 24).
Only the authors can say what is right here.
Judge's note: I viewed the p2 crops (enrolment dates, final visit timing) and the p3 crop (18 to 36 months). From 15 Nov 2000 to 30 Sep 2003 is about 34.5 months, so 36 cannot be reached under the stated dates. The upper bound may be a rounded design figure. Only the authors can say which is meant.
Second check: another model agreed
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Typo Introduction, p2: "as a mean of preventing death or major cardiovascular events" should read "as a means of preventing".
- p. 2 Introduction, end of first paragraph
as a mean of preventing death or major cardiovascular events
- p. 2 Introduction
as a mean of preventing death
- p. 2 Introduction
as a mean of preventing death or major cardiovascular
Judge's note: The page-2 crop shows 'as a mean of preventing' as printed. It is a wrong-word typo, not an extraction artefact.
Second check: none (judge only)
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Typo "200 mg per deciliter (5.18 mmol per liter)" does not match the paper's stated factor 0.02586, which gives 5.17. The other conversions (240→6.21, 70→1.81, 125→3.23) follow 0.02586.
- p. 2 Methods, patient population
200 mg per deciliter (5.18 mmol per liter)
- p. 4 Table 1 footnote
multiply by 0.02586
Judge's note: I checked the p2 text and the Table 1 footnote (multiply by 0.02586). 200*0.02586 = 5.172, which rounds to 5.17. The other printed conversions match 0.02586. The 5.18 figure matches the common factor 0.0259 instead. This is a trivial internal inconsistency.
Second check: none (judge only)
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Typo Stray space before the closing parenthesis in "(5.18 mmol per liter )" on p2.
- p. 2 Patient population
per liter ) or less
Judge's note: The page-2 crop shows a visible space between 'liter' and ')' in the typeset text. Cosmetic.
Second check: none (judge only)
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Typo Drug name misspelled in the concomitant-medications paragraph, p5: "clopidogrel or ticlodipine" should be ticlopidine.
- p. 5 Results, concomitant medications
clopidogrel or ticlodipine to 72 percent
- p. 5 Concomitant medications paragraph
clo- pidogrel or ticlodipine
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the drug is spelled 'ticlopidine'. The p5 crop shows 'ticlodipine' as printed.
Second check: none (judge only)
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Typo Figure 3 title: "Hazard Ratio for the the Primary End Point" has a duplicated "the".
- p. 7 Figure 3 caption title
Hazard Ratio for the the Primary End Point
- p. 7
). Figure 3. Hazard Ratio for the the Primary End Point o
Judge's note: The p7 crop shows the duplicated word in the typeset caption.
Second check: code check
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Typo Appendix: "Craigavaon Area Hospital, Portadown" should be Craigavon Area Hospital.
- p. 10 Appendix, last clinical center
Craigavaon Area Hospital, Portadown
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the hospital is Craigavon Area Hospital. The p10 crop shows 'Craigavaon' as printed.
Second check: none (judge only)
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Typo In the appendix list of centres, a two-name pair has a stray serial comma: "Scarborough Cardiology Research, Scarborough, Ont., Canada: A. Ricci, and B. Bozek". The fix is "A. Ricci and B. Bozek".
- p. 10 Appendix, centers list
A. Ricci, and B. Bozek
Judge's note: I checked the crop of PDF page 10 and the text layer at line 1364. The comma before "and" is in the printed text. The other two-name pairs around it are printed without a comma (for example "A. Ahmed and D. Vold", "T. Stuckey and S. Milks", "S. Kouz and M. Roy"), so this one is inconsistent with the rest. This is a cosmetic punctuation slip.
Second check: none (judge only)