Prophylactic Implantation of a Defibrillator in Patients with Myocardial Infarction and Reduced Ejection Fraction
2002 · paper · Clinical trials
A randomized trial of 1232 patients with a prior heart attack and reduced heart pumping function, comparing an implanted defibrillator with conventional therapy. Over about 20 months, mortality was 14.2% with a defibrillator versus 19.8% with conventional therapy.
0 findings
None that passed a second check.
3 minor (typos and the like; most checked by the judge only)
Wording The Abstract says "the prevalence of medication use at the time of the last follow-up visit were similar in the two treatment groups", and the Discussion says "The two groups were balanced". Table 1 gives diuretic use as "72" vs "81" percent.
- p. 1 Abstract, Results
the prevalence of medication use at the time of the last follow-up visit were similar in the two treatment groups
- p. 5 Discussion, first paragraph
The two groups were balanced and received appropriate therapy with standard cardiac agents
- p. 3 Table 1, Medications at last contact, Diuretics
Diuretics 72 81
Judge's note: Table 1 on page 3 shows diuretics at 72% (defibrillator group) and 81% (conventional group), ACE inhibitors at 68% vs 72% and amiodarone at 13% vs 10%. Most of the other drugs are identical or close. 'Similar' is a judgement call, and these medications were recorded after randomisation. The paper gives no test for the claim. The blanket wording passes over a 9-point gap in diuretic use. This is a minor wording point, not a data error.
Second check: another model agreed
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Wording The Methods say "76 hospital centers (71 in the United States and 5 in Europe)", but the Appendix's five non-US centres include two in Israel (Bikur Cholim Hospital, Jerusalem; Tel Aviv Medical Center, Tel Aviv).
- p. 2 Methods, Organization of the Trial
76 hospital centers (71 in the United States and 5 in Europe)
- p. 6 Appendix, investigator list
A. Medina, Bikur Cholim Hospital, Jerusalem, Israel
- p. 6 Appendix, investigator list
B. Belhassen, Tel Aviv Medical Center, Tel Aviv, Israel
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: Israel is not geographically in Europe. The Appendix (page 6 image and text) lists Magdeburg and Bad Nauheim in Germany, Leiden in the Netherlands, and Jerusalem and Tel Aviv in Israel, so 5 non-US centres. The count of 5 matches, but the label 'Europe' covers two Israeli sites. The authors may have used 'Europe' as a region that includes Israel, so this is filed as a query.
Second check: another model agreed
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Typo Affiliation footnote prints "(A.J.M, W.Z., J.P.D, M.W.B., M.L.A.)": the initials "A.J.M" and "J.P.D" have no final period, unlike all the other initials.
- p. 1 Affiliation footnote
(A.J.M, W.Z., J.P.D, M.W.B., M.L.A.)
Judge's note: I looked at the crop of the page 1 footnote. The printed text reads "A.J.M, W.Z., J.P.D, M.W.B., M.L.A." and every other set of initials ends with a period. This is a cosmetic punctuation slip.
Second check: none (judge only)