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Web references

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w6. Gaster AL, Slothuus Skjoldborg U, Larsen J, Korsholm L, von Birgelen C, Jensen S et al. Continued improvement of clinical outcome and cost effectiveness following intravascular ultrasound guided PCI: insights from a prospective, randomised study. Heart 2003;89:1043-9.

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Web Table A. Results of recalcuation of P values in the interval 0.04≤P<0.05 in abstracts of randomised clinical trials.



Data in the abstract

Authors’ method

My comments

Tsang (w1)

P<0.05, RR=2.0


Wrong. 2/135 vs 0/133. The main text notes RR=2.0 (1.77-2.26) (which gives P<0.0001). With Fisher, I got P=0.50, and with Review Manager, that adds 0.5 to the cells when any cell is empty, RR=4.93 (0.24-102). No reply from author.

Thies (w4)

OR=0.52 (0.24-0.89)


Wrong. Rates in per cent for completers; these correspond to 8/53 vs 17/57. Authors report P=0.0273. With chi-square I got P=0.065 without and P=0.11 with continuity correction. OR also wrong, and CI too narrow. I got OR=0.42 (0.16-1.07) or 0.44 (0.18-1.06), depending on method, and even if all patients had been included, it would be wrong. No reply from author.

Sato (w5)

P=0421 [sic], OR=6.1


Wrong. 1/109 vs 6/108. The main text notes P=0.0421, I got P=0.065 with Fisher. Author’s comment: acknowledges the error.

Gaster (w6)

P=0.04, OR=2.5


Wrong. Rates in per cent; these correspond to 42/54 vs 32/54. I got P=0.061 with Fisher. Author’s comment: confirmed rates but forgot to mention under Methods that the P-value resulted from a logistic regression analysis.

Sheu (w7)

P<0.05, RR=0.128 (0.016-0.979)

Chi-square, with Pearson’s correction, two-sided.

Doubtful. 2/44 vs 8/44 gives P=0.093 with adjusted chi-square. The authors excluded one of the two cases which gives P<0.05, but this post hoc exclusion seems unwarranted. No reply from author.

Arshad (w8)

OR=0.26 (0.07-0.96)

Chi-square or Fisher; also logistic regression.

Doubtful. 8/58 vs 17/62, authors reported P=0.08. They then adjusted for 10 factors and got P=0.04. Not clear why these 10 factors were chosen, e.g. one of them occurred for 13 vs 15 patients, although imbalance was given as the reason for the adjustments. Author’s comment: confounders also included.

Hughes (w9)

P=0.04, OR=3.2

Statistical methods not described in Methods, noted as "regression analyses" in Results.

Doubtful. 61 vs 54 patients. There was no difference in the unadjusted analysis the authors reported, OR 1.4 (0.6-3.5), P=0.45. Number of factors used for adjustment described as both 4 and 6. Two factors were chosen because of significant baseline difference, and 2 others because they "appeared to differ". Author’s comment: the correct number is 6; controlling for additonal factors did not change the OR much.

León (w10)

P<0.049, RR=4.14 (0.8-19)

Chi-square or Fisher.

Doubtful. 2/116 vs 8/114, I got P=0.058 with Fisher. The authors used one-sided alpha in the sample size calculation, and I got P=0.048 with one-sided Fisher. No reply from author.

Trivedi (w11)

P=0.04, RR=0.78 (0.61-0.99)

"crude rates and then, after adjustment for age, with the Cox regression method".

Doubtful. As there were 2686 patients, and the mean age differed by only 0.1 years, there was no need to adjust for age. Without adjustment, I got P=0.058. Author’s comment: adjusted because age is a strong risk factor. My comment: although this may have been perfectly reasonable in this particular case, the more general issue is that it is not likely that authors are equally inclined to adjust for a very small age difference in a large sample if the adjustment changes the P value in the opposite direction, from 0.04 to 0.058.

George (w12)

P<0.05, OR=4.64 (1.02-21.00)

Pearson chi-square.

Could be discussed. 9/20 vs 3/20. The authors did not correct for small numbers and found a chi-square of 4.29 (which gives P=0.038). I got P=0.085 with continuity correction and P=0.082 with Fisher. Author’s comment: agrees that they should have used an adjusted chi-square or Fisher.

Mion (w13)

OR=0.21 (0.05-0.99)

Chi-square likelihood ratio tests, two-sided.

Could be discussed. 2/326 vs 9/324. The authors reported in a table that they used chi-square or Fisher as appropriate. I got P=0.037 with Fisher, but an odds ratio that overlapped 1: OR=0.22 (0.05-1.01). Author’s comment: by mistake, we did not use intention-to-treat for this analysis which explains the slight difference in odds ratios, but Fisher was significant in both cases.

Basnyat (w14)

20/81 vs 9/74, "statistically significant reduction" of 50.6% in RR

Fisher or likelihood ratio tests.

Could be discussed. The authors reported P=0.043, I got P=0.063 with Fisher, but also RR=2.03 (1.01-4.08) in support of the authors’ abstract. No reply from author.

Bishai (w2)

P<0.05, OR=2.66

Logistic regression adjusted for one factor.

Could be discussed. 25/38 vs 13/31. The main text notes OR=2.66 (0.90-7.95) (which gives P=0.078). Author’s comment: used two methods; the CI for OR should have been 1.000544 to 7.086235 (computer print-out with correct event rates).

RR: relative risk; 95% confidence interval (CI) in brackets; Fisher: Fisher’s exact test; Author’s comment: personal communication.