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Table 4 Outcomes of the included trials

From: Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study

 

Statistician blinded prior to the final analysis

No (N=83)

Yes (N=69)

Unclear (N=27)

Statistically significant finding reported for primary outcome, n/N (%)

23/83 (28%)

19/69 (28%)

8/27 (30%)

Sample size planned

 Mean [SD]

1686.1 [5326.6]

1178.6 [2110.7]

1151.7 [1313.9]

 Median [25th, 75th centile]

540 [240, 900]

480 [312, 1200]

544 [308, 1180]

Sample size achieved

 Mean [SD]

1647 [5433.7]

1304.7 [2888.8]

1116 [1424.4]

 Median [25th, 75th centile]

540 [269, 1010]

475 [300, 1023]

487 [247, 1211]

Target sample size achieved, n/N (%)

56/83 (67%)

52/69 (75%)

15/27 (56%)

Percentage of target sample size achieved

 Mean [SD]

98.2 [25.7]

100.7 [24.8]

99 [60.1]

 Median [25th, 75th centile]

100.6 [97.4, 105.8]

101 [100, 107.4]

100 [83.2, 102.6]

Percentage of primary outcome data missing

 Mean [SD]

9.3 [11.4]

13.7 [10.4]

14.8 [15.6]

 Median [25th, 75th centile]

4 [1, 16]

11.5 [6, 20]

9 [3, 23]

 Unclear, n

1

3

0

Missing data imputed for primary outcome, n/N (%)

16/82 (20%)

20/65 (31%)

10/26 (38%)

 Unclear, n

1

4

1

  1. Unless otherwise specified the table displays frequencies and column percentages
  2. SD standard deviation