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Table 2 Mean changes from baseline in dabigatran and warfarin groups for the primary cognitive outcomes. Data report the marginal effects (least-squares mean change from baseline score) adjusted for age (in years), log of years of education, and raw baseline score (mITT population, no imputation). Contrast values are between-group differences in the least-square mean change (dabigatran–warfarin). A positive value of contrast indicates a relative improvement (or smaller cognitive decline) of the group treated with dabigatran. There was no correction for multiple testing. Cohen’s d shows the effect size (contrast) as a proportion of the variation (residual standard deviation) of the adjusted least-square mean change

From: Effects of dabigatran versus warfarin on 2-year cognitive outcomes in old patients with atrial fibrillation: results from the GIRAF randomized clinical trial

Cognitive assessment

Dabigatran

Warfarin

Difference (D-W) (95% CI)

P-value

Cohen’s d effect size

Mean

Mean

(SD)

N

(SD)

N

   

MMSE score

− 0.69 (− 1.18 to − 0.20)

83

− 0.57 (− 1.12 to − 0.01)

66

− 0.12 (− 0.88 to 0.63)

0.75

− 0.06

MoCA score

− 0.39 (− 0.94 to 0.16)

83

0.58 (− 0.04 to 1.19)

66

− 0.96 (− 1.80 to − 0.13)

0.02

− 0.39

NTB score

0.02 (− 0.06 to 0.10)

83

− 0.03 (− 0.12 to 0.06)

66

0.05 (− 0.07 to 0.18)

0.40

0.14

CGNT score

Composite score

− 0.06 (− 0.16 to 0.04)

68

0.09 (− 0.02 to 0.20)

56

− 0.15 (− 0.30 to 0.006)

0.06

− 0.36

Simple reaction time (AC)

0.33 (0.008 to 0.64)

74

0.76 (0.40 to 1.11)

60

− 0.43 (− 0.92 to 0.05)

0.08

− 0.32

Simple reaction time (RT)

5.86 (− 62 to 73)

74

− 168 (− 244 to − 93)

60

174 (71 to 277)

0.001

0.60

Sustained attention (AC)

− 1.40 (− 3.00 to 0.25)

75

− 1.00 (− 2.90 to 0.88)

58

− 0.39 (− 2.94 to 2.15)

0.76

− 0.06

Sustained attention (RT)

36 (− 28 to 99)

75

− 28 (− 100 to 45)

58

63 (− 35 to 161)

0.21

0.23

Selective attention (AC)

− 0.35 (− 4.80 to 4.13)

75

2.80 (− 2.20 to 7.90)

59

− 3.20 (− 10.10 to 3.78)

0.37

− 0.17

Selective attention (RT)

69 (− 106 to 245)

75

− 189 (− 388 to 11)

59

258 (− 15 to 531)

0.06

0.34

Divided attention (AC)

1.47 (0.29 to 2.65)

72

0.13 (− 1.18 to 1.43)

59

1.35 (− 0.46 to 3.15)

0.14

0.27

Divided attention (RT)

3.50 (− 55 to 62)

72

− 17 (− 82 to 48)

59

20.80 (− 69 to 111)

0.65

0.09

  1. AC accuracy, CGNT a composite score composed of the average of the Z-scores of the following computer-generated neuropsychological tests: simple reaction time, sustained attention, selective attention, and divided attention, MMSE Mini-Mental State Exam, MoCA Montreal Cognitive Assessment, NTB composite neuropsychological test battery consisting of the average of the Z-scores for Boston naming test, semantics verbal fluency, phonemic verbal fluency, trail making tests, clock-drawing test, and digit symbol substitution test, RT reaction time