Multiple Sclerosis Journal - October 2017 - 1535

LJM Blikman, J van Meeteren et al.
Table 4. Results of the linear mixed model analyses for the primary outcomes fatigue (CIS20r fatigue) and participation
(IPA).
Primary outcomes

CIS20r
fatigue

IPA
autonomy
indoors

IPA
family
role

IPA
autonomy
outdoors

IPA social
relations

IPA
work and
education

Overall
T8
T16
T26
T52
Overall
T8
T16
T26
T52
Overall
T8
T16
T26
T52
Overall
T8
T16
T26
T52
Overall
T8
T16
T26
T52
Overall
T8
T16
T26
T52

Crude model

Adjusted modela

B

p

95% CI

−0.81
2.64
−1.42
−3.54
−1.46
0.00
0.13
−0.07
−0.10
0.03
−0.00
−0.05
0.04
−0.03
0.05
0.00
0.05
−0.00
0.04
−0.09
0.19
0.22
0.15
0.22
0.17
−0.01
−0.06
−0.01
−0.06
0.10

0.58
0.18
0.48
0.08
0.47
0.97
0.22
0.52
0.38
0.78
1.00
0.72
0.78
0.81
0.72
0.97
0.66
1.00
0.77
0.49
0.02
0.03
0.15
0.03
0.10
0.92
0.70
0.93
0.69
0.52

−3.72
−1.23
−5.38
−7.49
−5.46
−0.17
−0.08
−0.29
−0.32
−0.19
−0.22
−0.31
−0.23
−0.30
−0.22
−0.20
−0.19
−0.25
−0.21
−0.34
0.03
0.03
−0.05
0.02
−0.03
−0.23
−0.36
−0.33
−0.38
−0.21

2.11
6.50
2.53
0.42
2.54
0.17
0.35
0.15
0.12
0.25
0.22
0.22
0.31
0.24
0.32
0.21
0.30
0.25
0.29
0.16
0.35
0.42
0.34
0.42
0.37
0.21
0.24
0.30
0.25
0.42

B

p

95% CI

−0.80
2.65
−1.49
−3.55
−1.45
0.03
0.16
−0.04
−0.07
0.06
0.02
−0.03
0.06
−0.01
0.07
0.02
0.07
0.01
0.05
−0.07
0.20
0.23
0.15
0.23
0.18
0.00
−0.05
0.00
−0.05
0.12

0.59
0.18
0.46
0.08
0.48
0.72
0.16
0.70
0.53
0.59
0.83
0.85
0.65
0.96
0.59
0.85
0.58
0.91
0.67
0.58
0.02
0.02
0.14
0.03
0.09
0.97
0.77
0.99
0.77
0.46

−3.73
−1.22
−5.46
−7.52
−5.46
−0.15
−0.06
−0.26
−0.29
−0.16
−0.20
−0.29
−0.21
−0.28
−0.20
−0.19
−0.18
−0.24
−0.20
−0.32
0.03
0.03
−0.05
0.02
−0.03
−0.22
−0.35
−0.32
−0.36
−0.20

Effect
size
2.12
6.52
2.48
0.42
2.56
0.21
0.37
0.18
0.15
0.28
0.25
0.24
0.34
0.27
0.35
0.23
0.31
0.26
0.30
0.18
0.36
0.43
0.35
0.43
0.38
0.23
0.26
0.32
0.27
0.44

0.09
0.31
0.18
0.36
0.16
0.04
0.27
0.06
0.10
0.08
0.03
0.05
0.08
0.01
0.09
0.03
0.12
0.02
0.07
0.09
0.38
0.44
0.29
0.43
0.33
<0.01
0.06
<0.01
0.06
0.14

CI: confidence interval; CIS20r: Checklist Individual Strength, domain fatigue: higher scores indicate more fatigued; IPA: Impact on
Participation and Autonomy: higher scores reflect greater restrictions in participation and autonomy.
Crude analyses are adjusted for the baseline value of the particular outcome.
aAdjusted for centre, gender, exacerbations and time since diagnosis. The effect size is calculated by the regression coefficient (of the
adjusted model) divided by the pooled standard deviation.

One of the limitations of this study could be the sample size, as we were unable to enrol all 90 participants and the percentages of drop-outs (19% in the
ECM group, 11.4% in the control group) was near
the estimated 20% attrition rate.16 Nonetheless,
because the 95% CIs of the primary outcomes were
generally small, we suspect that a larger sample size
would not have resulted in different outcomes and
that our study was adequately powered. Furthermore,
although control conditions are an essential method
of managing threats to internal validity, they may

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also have unintended effects on the primary outcomes. The small positive effects in our control
group can be the result of the provided information,
but can also be attributed to a heightened awareness
because of the attention, or to the possibility that the
MS nurses have inadvertently provided advise.
Another limitation is the generalizability to all persons with MS because all our participants were
ambulant. Finally, selection bias can be caused by
factors such as time constraints, distance constraints
or the severity of fatigue.

1535
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Table of Contents for the Digital Edition of Multiple Sclerosis Journal - October 2017
