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Abstract
The consequences of traumatic brain injury (TBI) for health-related quality of life (HRQoL) are poorly investigated,
and a TBI-specific instrument has not previously been available. The cross-cultural development of a new measure
to assess HRQoL after TBI is described here. An international TBI Task Force derived a conceptual model from
previous work, constructed an initial item bank of 148 items, and then reduced the item set through two successive
multicenter validation studies. The first study, with eight language versions of the QOLIBRI, recruited 1528
participants with TBI, and the second with six language versions, recruited 921 participants. The data from 795
participants from the second study who had complete Glasgow Coma Scale (GCS) and Glasgow Outcome Scale
(GOS) data were used to finalize the instrument. The final version of the QOLIBRI consists of 37 items in six scales
(see Appendix). Satisfaction is assessed in the areas of Cognition, Self, Daily Life and Autonomy, and Social
Relationships, and feeling bothered by Emotions, and Physical Problems. The QOLIBRI scales meet standard
psychometric criteria (internal consistency, a 0.750.89, test-retest reliability, rtt 0.780.85). Test-retest reliability
(rtt 0.680.87) as well as internal consistency (a 0.810.91) were also good in a subgroup of participants with
lower cognitive performance. Although there is one strong HRQoL factor, a six-scale structure explaining additional variance was validated by exploratory and confirmatory factor analyses, and with Rasch modeling. The
QOLIBRI is a new cross-culturally developed instrument for assessing HRQoL after TBI that fulfills standard
psychometric criteria. It is potentially useful for clinicians and researchers conducting clinical trials, for assessing
the impact of rehabilitation or other interventions, and for carrying out epidemiological surveys.
Key words: multi-national study; outcome instrument; quality of life; traumatic brain injury
Introduction
he ultimate goal of health care and rehabilitation following traumatic brain injury (TBI) is to return a person
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activity limitations and participation restrictions, all of which
affect the persons self-image and ability to cope (Dikmen
et al., 2003; von Steinbuchel et al., 2005a). These consequences
may have a major impact upon the persons quality of life
(QoL), as defined by the World Health Organization QoL
Group (1998, p. 153): . . . an individuals perception of their
position in life in the context of the culture and value systems
in which they live and in relation to their goals, expectations,
standards and concerns . . . The WHO definition views QoL
as a broad concept, which is largely consistent with Corrigan
and Bogners (2004) analysis of critical dimensions in rehabilitation research, emphasizing activities, social integration,
and participation as key outcomes.
The concept of HRQoL refers to the specific effects of health
on well-being and functioning (Guyatt et al., 1989; von
Steinbuchel, 1995). HRQoL represents a persons perspective
on his or her subjective health condition, functioning, and
well-being in the domains of physical, psychological (emotional and cognitive), social, and daily life (von Steinbuchel
et al., 2005a). The person is viewed as the best expert on his or
her QoL, and the measurement of this multidimensional
concept is usually accomplished via self-rating; only in cases
of severe cognitive impairment is observer rating preferred
(Bullinger and von Steinbuchel, 2001).
Since English (1904), outcomes of TBI, however, have been
traditionally assessed by functional indicators, such as disability recovery (Arango-Lasprilla et al., 2007; Jennett and
Bond, 1975; Wilson et al., 1998), health status (Corrigan and
Bogner, 2004; Findler et al., 2001; Klonoff et al.,1986; LippertGruner et al., 2007; McCarthy et al., 2006), return to work or
productivity (Klonoff et al., 2006; McCrimmon and Oddy,
2006; Shames et al., 2007), psychosocial and social functioning
(Arango-Lasprilla et al., 2007; Schonberger et al., 2006; Tomberg et al., 2005), and community participation (Cattelani
et al., 2008; Corrigan and Bogner, 2004; Mascialino et al., 2009;
Powell et al., 1998). While these outcomes are certainly related
to HRQoL in TBI, they do not incorporate the perspective of
subjective well-being of HRQoL (von Steinbuchel et al.,
2005a). The National Institutes of Health (NIH) consensus
development panel on rehabilitation of persons with TBI
(1999) therefore recommended the use of generic HRQoL
measures.
The most frequently administered generic health status
measures in TBI have been the SF-36 Health Survey (Andelic
et al., 2009; Callahan et al., 2005; Findler et al., 2001; Hawthorne et al., 2009; MacKenzie et al., 2002; Ware et al., 1995,
1993), and the Sickness Impact Profile (Corrigan et al., 1998;
Klonoff et al., 1986; Pagulayan et al., 2008, 2006). Both of these
instruments show lower subjectively rated health in persons
with TBI than in healthy persons. The measurement of life
satisfaction in TBIa component of HRQoLhas been most
commonly performed with the Satisfaction with Life Scale
(Diener et al., 1985), which shows improvements in satisfaction with life after treatment (Dahlberg et al., 2007), and an
association of life satisfaction with healthy and productive
lifestyles (Pierce and Hanks, 2006). Importantly, these generic
HRQoL instruments allow for general comparative studies
between different populations.
In comparison, disease- or condition-specific HRQoL instruments are assumed to be more sensitive to specific health
conditions, and therefore allow the collection of more focused
and precise information. It is only recently that HRQoL has
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FIG. 1. Stages in the development of the QOLIBRI (HRQoL, health-related quality of life; TBI, traumatic brain injury;
QOLIBRI, Quality of Life After Brain Injury scale). 1Bullinger et al., 2002. 2Von Steinbuchel et al., 2005. 3Truelle et al., 2008.
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language. Ethics clearance was obtained by each of the participating centers.
In this second study we aimed to recruit 120150 participants per language. Patients were stratified by clinical severity of TBI as assessed by the GCS. Test-retest reliability was
investigated in a subset of at least 30 participants per language
by second administration of the questionnaire after a 2-week
interval.
The questionnaires were administered in one of four
modes: by self-report (mail), self-report (participant present at
the clinic), face-to-face interview, or administration over the
telephone.
Measures
The preliminary QOLIBRI version for this second validation study consisted of 49 items, 43 of which were arranged in
seven scales, with the remaining six items composed as an
overall scale for use as an independent screening instrument
(von Steinbuchel et al., in prep.). Four scales assessed satisfaction with Cognition (7 items), Emotion and self-perception (8), Activities of daily living (ADLs) and
Autonomy (8), and Social relationships (6). Three scales
assessed feeling bothered by Negative feelings (5), Restrictions and problems (4), and Physical condition (4).
Responses were recorded on a 5-point scale: Not at all/
Slightly/ Moderately/ Quite/ Very. The bothered items
had an additional (filter) category: Does not apply. During
scoring, the endorsements of this option were coded as Not
at all. Scale scores were presented on a percentage scale
(0100).
Demographic characteristics of participants were collected,
including country, language, gender, age, relationship status,
educational attainment, labor force participation, and social
participation.
Subjective health status was assessed through administration of the SF-36 Health Survey (version 1; Ware et al., 1993;
one country used version 2 with subsequently transformed
data; Ware and Kosinski, 1996; Ware, 2000). Two summary
scales are reported, the Physical Component Summary (PCS)
and the Mental Component Summary (MCS).
Current health conditions were assessed through a list of 28
common health conditions (adapted from the WHOQoL
project; von Steinbuchel et al., 2006). Clinical data extracted
from participants medical records included the date of injury,
cause of injury, site of major head injury, and the worst GCS
score in the first 24 h, classified into minor (1315), moderate
(912) and severe (38; Rimel et al., 1982). The presence of
comorbid health conditions was also recorded (epilepsy,
hemiparesis, vision and hearing problems, extracerebral injuries, communication, attention and memory dysfunction,
executive function, and affective and behavioral disorders), as
were details of participation in rehabilitation and the use of
anticonvulsive, psychotropic, and recreational drugs.
Depression and anxiety were assessed with the Hospital
Anxiety and Depression (HADS) scale (Zigmond and Snaith,
1983), which was available in all languages. A score of > 8 was
taken to indicate probable morbidity (Olsson et al., 2005).
Cognitive status was measured in a subsample of participants using either the Mini Mental State Examination (MMSE;
Folstein et al., 1975), or the Telephone Interview for Cognitive
Status (TICS; Brandt et al., 1988), which was translated into
Gender
Age (years)
Employment status
Relationship status
Living arrangements
Glasgow Coma Scale
score (1st 24 h worst)
Major lesion
Number of comorbid
health conditions
Self-reported health
status
Dutch
English
Finnish
French
German
Italian
Male
Female
1730
3144
4568
Employed full-time
Single
Partnered
Past partnered
Independent
Supported
Severe: 38
99
97
157
148
155
139
573
222
271
247
277
170
302
351
90
420
320
464
(12%)
(12%)
(20%)
(19%)
(19%)
(17%)
(72%)
(28%)
(34%)
(31%)
(35%)
(23%)
(41%)
(47%)
(12%)
(57%)
(43%)
(58%)
Moderate: 912
Mild: 1315
None
Focal
Diffuse
<1 year
1 to <2 years
2 to <4 years
4 to 18 years
03
76
255
117
418
250
93
102
203
394
315
(10%)
(32%)
(15%)
(53%)
(32%)
(12%)
(13%)
(26%)
(50%)
(41%)
46
7 or more
Healthy
225 (29%)
236 (30%)
530 (72%)
Unhealthy
Glasgow Outcome
Severe disability
ScaleExtended score
Moderate disability
Good recovery
203 (28%)
143 (18%)
433 (54%)
219 (28%)
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sponses for all items were in the expected order. Winsteps
produces two fit statistics: infit weights responses of people
whose performance is close to the item value, while outfit is
sensitive to outlying scores (Bond and Fox, 2007). Deviation of
infit from expectation is generally regarded as more important for measurement than outfit deviation. For large sample
sizes the mean square is preferred to the Z statistic as a
measure of fit, and satisfactory fit is indicated by values between 0.7 and 1.3 (Smith et al., 2008). Values > 1.3 indicate
lack of item fit with the unidimensional model, while values < 0.7 suggest items are over-fitting or redundant.
To study whether the structure of the questionnaire (specifically the division into separate scales) was justified we
used factor analysis. The dimensionality of the final version
was examined using principal component analysis (PCA).
PCA using both a forced one-factor solution and a six-factor
solution that resulted when Kaisers criterion (eigenvalues > 1) was applied, and oblique rotation (promax method
with the assumption of correlated scales) was performed.
Finally we studied the structure of the questionnaire using
confirmatory factor analysis (CFA; using structural equation
modeling [SEM] in AMOS 8.0), an approach that allows various statistics for overall fit to be calculated. Good fit indicates
that the assumed grouping of items into scales adequately
reflects the empirical patterns of relationships between items.
Within CFA the observed variables corresponded to the individual items of the QOLIBRI, and the latent variables to the
factors that represent the six QOLIBRI subscales. The existence of substantial intercorrelations between the factors, in
turn, suggested the existence of a second-order latent variable
representing general HRQoL. This type of confirmatory factor
analysis is common within HRQoL research, with HRQoL as
a higher-order construct, conceptually reflecting the multidimensionality of the construct, and the various underlying
factors (with substantial covariance) representing specific dimensions. The analysis was restricted to complete cases after
imputing missing values as described below (n 787). Maximum likelihood was applied for parameter estimation in
CFA analysis. Selected indices (CFI, RMSEA, and chi-square
statistics) were observed to evaluate the overall fit of the data
to the final model of the QOLIBRI. Interpretation of fit statistics was carried out along the cut-off criteria presented by
Hu and Bentler (1999).
Results
Descriptives
A total of 921 participants were enrolled. There were 126
cases with missing GCS, which were excluded from subsequent analysis. In the remaining 795 cases, some data were
missing to varying degrees. For demographics concerning
gender and age 100% of the data were present, and for living
arrangements, employment status, and relationship status
93% were present. In the clinical data 100% were present for
GCS and GOSE, for major lesion location and years since injury 99%, 98% for numbers of comorbid health conditions,
and 92% for self-reported health situation.
There were less than 5% missing responses for single QOLIBRI items (e.g., participation in work, 4.4%). HADS anxiety and depression scores were present for 99% and SF-36
scores for 96% of the sample. For the QOLIBRI, means were
calculated for each scale, and prorated if up to 33% of
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Social relationships
Daily life
and autonomy
Self
Cognition
Scale
Affection towards
others
Family members
Independence
Get out and about
Domestic activities
Basic personal needsa
Run personal finances
Participation in work
Social-leisure activities
In charge of life
Energy
Control emotionsc
Motivation
Self-esteem
Way you look
Achievements
Self-perception
Own future
Concentrate
Express yourself
Remember
Plan and problem solve
Decisions
Find way
Speed of thinking
Item
1.12
1.06
3.95
1.17
1.17
1.16
0.82
1.19
1.39
1.28
1.11
1.17
1.15
1.12
1.22
1.10
1.19
1.09
1.20
1.15
1.04
1.17
1.10
1.11
1.11
1.13
SD
3.85
3.60
3.82
3.77
4.51
3.86
3.27
3.49
3.72
3.17
3.23
3.42
3.36
3.45
3.77
3.38
3.22
3.22
3.53
3.07
3.61
3.57
3.84
3.32
Item descriptives
Mean
0.4
0.4
0.1
0.4
0.1
0.3
0.3
4.4
0.8
0.3
0.4
0.4
0.3
0.4
0.3
0.4
1.0
0.9
0.1
0.5
0.3
0.4
0.4
0.3
0.6
Percent
missing
0.618
0.86
0.535
0.600
0.629
0.697
0.693
0.701
0.651
0.625
(0.580)
0.651
0.739
0.599
0.652
0.780
0.678
0.708
0.681
0.674
0.751
0.673
0.625
0.727
CITC
0.635
Yes
MAP analysis
Frequency
problem
0.80
0.62
0.80
0.71
1.82
0.91
0.32
0.44
0.61
0.21
0.26
0.40
0.40
0.45
0.74
0.44
0.25
0.14
0.39
0.13
0.51
0.53
0.74
0.30
Reliability analysese
Skewness
0.797
0.792
0.862
0.856
0.850
0.841
0.841
0.840
0.847
0.874
(0.885)
0.871
0.859
0.877
0.871
0.855
0.867
0.875
0.879
0.879
0.870
0.879
0.885
0.873
Alpha if item
removed
100%
100%
100%
Scaling
success
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Pain
Epilepsya
Smell/tastea
See/hear
TBI effects
Slowness/clumsy
Drivingb
Legal actionsb
Other injuries
Loneliness
Boredom
Anxiety
Depression
Anger/aggression
3.75
4.83
4.33
4.05
3.19
3.84
4.02
4.09
3.75
4.10
3.87
3.83
3.73
3.78
3.71
3.45
2.96
3.33
1.38
0.69
1.24
1.21
1.31
1.30
1.40
1.36
1.41
1.19
1.27
1.31
1.33
1.31
1.16
1.44
1.48
1.11
0.4
0.6
0.5
0.5
2.5
0.5
0.9
1.3
0.8
0.5
0.5
1.1
0.8
0.5
0.4
0.8
2.5
0.3
0.77
4.32
1.79
1.16
0.21
0.86
1.17
1.25
0.74
1.21
0.86
0.84
0.75
0.78
0.70
0.48
0.05
0.31
Yes
Yes
0.407
0.614
0.490
0.534
(0.421)
(0.394)
0.564
0.613
0.625
0.684
0.689
0.562
0.611
0.598
0.593
0.564
0.748
0.677
0.723
0.706
(0.752)
(0.765)
0.695
0.807
0.803
0.786
0.785
0.821
0.796
0.801
0.803
0.805
Yes
Yes
Physical
conditiond
Restrictions
and problemsd
Emotions
Friends
Partner
Sex life
Attitudes of others
100%
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Table 3. QOLIBRI Scale Means and Standard Deviations, and Cronbachs a for All Data, and Separately
for Each Language Version and for a Subgroup with Low and High MMSE/TICS Scores
Scale
Mean
SD
All
Dutch
English
Finnish
French
German
Italian
Low MMSE/
TICS
High MMSE/
TICS
Cognition
Self
Daily life
and autonomy
Social relationships
Emotions
Physical problems
QOLIBRI Total
61.26
60.03
66.41
21.77
21.96
22.38
0.89
0.89
0.87
0.89
0.84
0.82
0.92
0.90
0.93
0.92
0.90
0.88
0.83
0.87
0.76
0.91
0.90
0.90
0.84
0.86
0.85
0.91
0.88
0.88
0.91
0.89
0.90
63.65
71.71
67.91
64.58
22.64
24.69
23.47
18.24
0.83
0.83
0.75
0.95
0.74
0.64
0.69
0.94
0.88
0.88
0.80
0.97
0.87
0.83
0.79
0.95
0.77
0.79
0.64
0.92
0.85
0.84
0.83
0.96
0.80
0.85
0.70
0.94
0.84
0.86
0.81
0.95
0.83
0.76
0.76
0.96
MMSE, Mini Mental State Examination; TICS, Telephone Interview for Cognitive Status; QOLIBRI, Quality of Life After Brain Injury.
Table 4. Test-Retest Intra-class Correlations with 95% Confidence Intervals for All Retested
Participants, and Those with Low Scores on MMSE or TICS (Borderline or Impaired Cognition)
versus Those with Scores in the Normal Range
All
QOLIBRI scale
Cognition
Self
Daily life
and autonomy
Social relationships
Emotions
Physical problems
QOLIBRI total
Low MMSE/TICS
High MMSE/TICS
ICC
Lower
95% CI
Upper
95% CI
ICC
Lower
95% CI
Upper
95% CI
ICC
Lower
95% CI
Upper
95% CI
380
381
379
0.81
0.84
0.83
0.77
0.81
0.80
0.84
0.87
0.86
84
84
84
0.81
0.84
0.85
0.72
0.76
0.77
0.87
0.89
0.90
121
121
121
.80
.85
.82
.72
.80
.75
.85
.90
.87
381
376
343
380
0.79
0.78
0.84
0.91
0.75
0.73
0.81
0.89
0.83
0.81
0.87
0.92
84
82
82
84
0.70
0.68
0.80
0.87
0.58
0.54
0.69
0.80
0.80
0.78
0.87
0.91
121
121
121
121
.80
.69
.88
.90
.72
.58
.83
.86
.86
.77
.91
.93
MMSE, Mini Mental State Examination; TICS, Telephone Interview for Cognitive Status; QOLIBRI, Quality of Life After Brain Injury; CI,
confidence interval; ICC, intra-class correlation.
Finnish
Cognition
Self
Daily life
and autonomy
Social relationships
Emotions
Physical problems
QOLIBRI total
ICC
German
QOLIBRI scale
ICC
French
1175
TICS < 33; n 84) internal consistency was comparable to
persons with normal cognitive status (MMSE > 27 or
TICS > 32; n 121); in the former group, the lowest a was 0.81
for the Physical problems scale, for which it was 0.76 in the
latter group.
ICC
Test-retest reliability
56
54
55
56
0.79
0.76
0.83
0.88
49
49
49
49
Table 6. QOLIBRI Scale Percentage Scores and Standard Deviations for Retested Participants
at the First and Second Test
First assessment
Cognition
Self
Daily life and autonomy
Social relationships
Emotions
Physical problems
QOLIBRI total
Second assessment
Mean %
SD
Mean %
SD
380
381
379
381
376
343
380
63.3
60.5
68.3
64.8
72.2
69.5
65.6
20.5
21.8
21.6
22.6
24.2
22.7
17.8
64.9
60.6
68.6
65.2
73.8
71.6
66.5
21.0
20.5
22.2
21.8
24.5
22.5
18.2
2.22
0.20
0.37
0.47
1.89
3.07
2.09
0.03
0.84
0.71
0.64
0.06
0.02
0.04
0.08
0.00
0.01
0.02
0.07
0.09
0.05
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Table 7. Measures of Item Difficulty and Fit from Rasch Analysis of Each of the QOLIBRI Scales
Item difficulty measure Infit MNSQ Infit Z Outfit MNSQ Outfit Z
Cognition
Find way about
Plan & problem solve
Express yourself
Decisions
Speed of thinking
Concentrate
Remember
0.72
0.30
0.27
0.18
0.27
0.42
0.78
1.20
0.82
1.00
1.06
0.90
0.95
1.06
3.54
3.85
0.11
1.14
2.16
1.07
1.29
1.24
0.80
1.00
1.07
0.90
0.94
1.08
3.75
4.14
0.01
1.36
2.06
1.13
1.52
Achievements
Way you look
Motivation
Self-perception
Self-esteem
Own future
Energy
0.60
0.11
0.08
0.03
0.09
0.28
0.39
1.06
1.19
1.05
0.70
0.82
1.00
1.14
1.18
3.61
1.00
6.69
3.77
0.07
2.79
1.11
1.21
1.04
0.68
0.79
0.98
1.15
1.81
3.84
0.77
7.06
4.23
0.34
2.91
0.26
0.24
0.22
0.17
0.08
0.22
0.57
0.83
1.27
0.96
0.85
0.87
1.06
1.15
3.40
4.49
0.76
3.08
2.58
1.13
2.81
0.84
1.33
0.97
0.84
0.87
1.04
1.21
2.96
4.87
0.58
3.10
2.48
0.81
3.50
Family members
Affection to others
Friends
Partner
Attitudes of others
Sex life
0.69
0.49
0.21
0.24
0.34
0.82
0.93
0.90
0.98
1.03
1.10
1.03
1.40
2.03
0.45
0.53
1.90
0.68
0.91
0.88
0.97
1.02
1.10
1.07
1.63
2.25
0.62
0.31
1.98
1.06
Loneliness
Boredom
Anxiety
Anger/aggression
Depression
0.37
0.03
0.06
0.12
0.22
1.04
1.03
0.88
1.21
0.87
0.75
0.63
2.24
3.63
2.43
0.97
1.01
0.86
1.20
0.82
0.42
0.11
2.29
3.11
3.11
See/hear
Slowness/clumsy
Other injuries
Pain
TBI effects
0.15
0.03
0.02
0.4
0.6
0.96
0.92
1.07
1.21
0.85
0.7
1.6
1.4
3.5
3.3
0.92
0.86
1.09
1.25
0.83
1.2
1.9
1.4
3.2
3.6
Self
Social relationships
Emotions
Physical problems
Items within each scale are ordered by item difficulty (i.e., from most likely to least likely to be endorsed positively).
MNSQ, mean square; QOLIBRI, Quality of Life After Brain Injury; TBI, traumatic brain injury.
1177
fit 1.41), sex life (infit 1.30), other injuries (infit 1.30),
pain (infit 1.31), and seeing/hearing (infit 1.36). The
results of this analysis give moderate support to a unidimensional model, but also indicate that some of the items in
the Social relationships and Physical problems scales
have a poor fit with a unidimensional model.
Exploratory factor analyses
The results of two principal components analyses (PCA)
are shown in Table 8. Loadings on the first component of a
Item
First principal
component
Communality Factor 1 Factor 2 Factor 3 Factor 4 Factor 5 Factor 6
Cognition
Concentrate
Express yourself
Remember
Plan and problem solve
Decisions
Find way
Speed of thinking
0.681
0.641
0.629
0.705
0.693
0.591
0.687
0.651
0.594
0.605
0.708
0.627
0.523
0.642
Energy
Motivation
Self-esteem
Way you look
Achievements
Self-perception
Own future
0.669
0.672
0.699
0.587
0.666
0.733
0.678
0.562
0.550
0.694
0.493
0.580
0.728
0.588
Independence
Get out and about
Domestic activities
Run personal finances
Participation work
Social & leisure activities
In charge of life
0.691
0.662
0.634
0.565
0.644
0.678
0.714
0.663
0.659
0.601
0.399
0.510
0.502
0.622
0.585
0.530
0.580
0.443
0.510
0.614
0.660
0.616
0.589
0.591
0.574
0.506
Loneliness
Boredom
Anxiety
Depression
Anger/aggression
0.562
0.482
0.552
0.590
0.474
0.596
0.620
0.677
0.685
0.516
Slow/clumsiness
Other injuries
Pain
See/hear
TBI effects
0.550
0.477
0.465
0.386
0.642
0.540
0.571
0.505
0.491
0.585
0.755
0.753
0.745
0.738
0.620
0.692
0.722
0.279
Self
0.649
0.651
0.826
0.705
0.720
0.849
0.724
Daily life
0.731
0.773
0.749
0.482
0.443
0.342
0.569
0.281
0.279
Social
0.251
0.719
0.730
0.691
0.758
0.663
0.498
0.256
0.315
Emotions
0.265
0.316
0.634
0.796
0.826
0.747
0.708
Physical
0.574
0.753
0.587
0.748
0.518
Shown are 1 forced single-factor solution (column 3), and 1 six-factor solution (eigenvalues > 1; columns 410). Factor loadings > .25 are
shown.
QOLIBRI, Quality of Life After Brain Injury; TBI, traumatic brain injury.
CHEL ET AL.
VON STEINBU
1178
Cognition
Self
Daily life
and autonomy
Social relationships
Emotions
Physical problems
QOLIBRI total
Scale No.
QOLIBRI scales
1
1
2
3
0.65
0.70
0.71
4
5
6
7
0.48
0.47
0.55
0.82
0.59
0.53
0.50
0.85
0.56
0.48
0.57
0.86
0.49
0.37
0.73
0.53
0.72
0.72
Discussion
The parallel, consensual, and cross-cultural development of
this new specific instrument for the assessment of HRQoL of
persons after TBI represents a distinctive and unusual approach.
The different language samples were generally collected as
convenience samples (with two exceptions: Germany and
Australia), which is a common strategy in this type of instrument development study (Hawthorne et al., 2006). The
wide variation represents an advantage for this type of study
because it ensures future applicability to a wide range of patients. The relatively small number per language sample,
however, presents a limitation for analyses on the language
level.
For use in international multi-centre studies, the content as
well as metric equivalence of an instrument needs to be
demonstrated (Bullinger et al., 1993; Stucki et al., 1997). Thus
the translation of HRQoL instruments requires a standardized
process, including translation, back translation, review, cognitive debriefing, and harmonizations of the different language translations. We ensured comparability of the different
translations by following accepted guidelines concerning
cognitive debriefing in each set of language and harmonization procedures (von Steinbuchel et al., 2002; Acquadro et al.,
1996). Cross-cultural development also includes the demonstration of comparable metric properties for the whole sample, as well as for the different languages, in particular with
respect to internal consistency, reliability, factor structure,
and validity (von Steinbuchel et al., 2010).
The results of the present study indicate favorable psychometric properties of the QOLIBRI. In spite of the variation
in demographic and clinical characteristics, internal consistency and test-retest reliability are acceptable to good, both in
the total sample and in different language groups. The testretest reliability of the QOLIBRI is similar to that of the EBIQ
(Sopena et al., 2007), a patient-reported outcome measure
developed for TBI.
Reliabilities for the individual QOLIBRI scales were also
good in the subgroup with poorer cognitive performance. The
lowest reliability was recorded for the Emotions scale, an
area in which some fluctuation might be expected.
A concern with self-report instruments in TBI is the potential lack of insight that may be experienced by those with
cognitive impairment. Experience in diseases such as dementia suggests that subjective HRQoL judgments can be
obtained reliably, even in people with substantial cognitive
1179
QOL_01
ERR_01
QOL_02
ERR_02
QOL_03
ERR_03
QOL_04
ERR_04
QOL_05
ERR_05
QOL_06
ERR_06
QOL_07
ERR_07
,67
QOL_08
ERR_08
,69
QOL_09
ERR_09
QOL_10
ERR_010
QOL_11
ERR_11
QOL_12
ERR_12
QOL_13
ERR_13
QOL_14
ERR_14
,75
QOL_15
ERR_15
,74
QOL_16
ERR_16
QOL_17
ERR_17
QOL_18
ERR_18
QOL_19
ERR_19
QOL_20
ERR_20
QOL_21
ERR_21
,74
QOL_22
ERR_22
,72
QOL_23
ERR_23
QOL_24
ERR_24
QOL_25
ERR_25
QOL_26
ERR_26
QOL_27
ERR_27
QOL_28
ERR_28
QOL_29
ERR_29
QOL_30
ERR_30
QOL_31
ERR_31
QOL_32
ERR_32
QOL_33
ERR_33
QOL_34
ERR_34
QOL_35
ERR_35
QOL_36
ERR_36
QOL_37
ERR_37
,76
,73
,71
COGNITION
,80
,72
,65
,77
,72
,78
,79
SELF
,64
,71
,82
,72
,57
,80
,69
,54
,58
,72
DAILY_LIFE
,66
,68
,70
,75
,62
,67
,64
,72
,54
SOCIAL
,60
,61
,64
,72
,56
,70
,68
,75
,47
EMOTION
,78
,63
,67
,65
,61
PHYSICAL
,58
,45
,77
FIG. 2. Model of the structure of QOLIBRI items and scales, and path coefficients as revealed by SEM analysis (Quality of
Life After Brain Injury scale; SEM. structural equation modeling).
CHEL ET AL.
VON STEINBU
1180
impairment (Brod et al., 1999; Novella et al., 2001; Wlodarczyk et al., 2004). The relationship between reliability of
reports and cognitive status, however, is an issue that has not
been properly addressed in head injury (Riemsma et al., 2001).
This study showed that internal consistency (i.e., Cronbachs
a) for participants with poor cognitive performance was satisfactory, and test-retest reliability was good for the QOLIBRI.
This study, however, did not include detailed neuropsychological testing of cognitive functioning, which presents a topic
for future research. On the other hand, the majority of participants were severely injured. We conclude that the reliability of the QOLIBRI is satisfactory to good, even when
some cognitive impairment is present, and may be appropriate for the great majority of persons after TBI.
The conceptual model of HRQoL, on which the QOLIBRI
descriptive system was based, initially suggested a seven-,
then a six-dimensional model with four satisfaction scales
and three bothered scales, which were then collated into
two scales following psychometric examination. The PCA and
SEM analyses support this six-factor structure of the QOLIBRI
in a second-order latent variable model. Also, RASCH
analysis based on the presented results does not support
unidimensionality for all the items, and instead suggests a
multi-factorial structure. However, there is potential to develop, in future research, a QOLIBRI short form with a
reduced number of items and dimensions.
The final descriptive system of the QOLIBRI provides both
for an HRQoL profile across six domains of life, and also a
total index of HRQoL. The data from the various analyses
suggest that where a rich profile description of HRQoL is
required, the individual domain scores will provide this.
When used in evaluation studies, shifts in individual domains
will reflect areas of life where gains consequent to treatment
are made. In contrast, where an index of HRQoL is required,
this index can be used to assess the impact of treatments on
overall HRQoL as measured by QOLIBRI total score.
A limitation of the study was that the number of participants was too small for most language samples to confirm the
QOLIBRI factor structure within each language. Examination
of the factor structure in some of the larger samples of the first
validation study, however, confirms the structure. Rasch
analysis suggests a certain amount of redundancy at the item
level. A short six-item screening measure is already available
with the Overall items (psychometric properties will be
reported in von Steinbuchel et al., in prep.); the use of the
different versions will depend on the research questions to be
answered.
The development of the QOLIBRI descriptive system in
two large multi-national samples of persons after TBI has
resulted in an instrument with good psychometric properties.
Specific information on the validity of the scale can be found
in the other article on QOLIBRI in this issue (von Steinbuchel
et al., 2010). The results of this investigation of the validity of
the QOLIBRI show the expected confirmatory patterns of
correlations with instruments assessing disability, emotion,
and subjective health status, including the GOSE, HADS, and
SF-36. A multiple regression analysis showed that the main
correlates of the total QOLIBRI score were emotional state
(HADS depression and anxiety), amount of help needed,
outcome on the GOSE, and number of comorbid health conditions. Together these five variables accounted for 58% of the
variance.
1181
state of patients for the clinician. J. Psychiatr. Res. 12, 189
198.
Gerin, P., Dazord, A., Boissel, J.P., Hanauer, M.T., Moleur, P.,
and Chauvin, F. (1989). Quality of life assessment in therapeutic trials. Conceptual aspects and presentation of a Questionnaire. Therapie 44, 355364.
Guyatt, G.H., Veldhuyzen van Zanten, S.J., Feeny, D.H., and
Patrick, D.L. (1989). Measuring quality of life in clinical
trials: a taxonomy and review. Can. Med. Assoc. J. 140,
14411448.
Hawthorne, G., Davidson, N., Quinn, K., McCrate, F.,
Winkler, I., Lucas, R., Kilian, R., and Molzahn, A. (2006).
Issues in conducting cross-cultural research: implementation of an agreed international procotol designed by the
WHOQOL Group for the conduct of focus groups eliciting
the quality of life of older adults. Qual. Life Res. 15, 1257
1270.
Hawthorne, G., Gruen, R.L., and Kaye, A.H. (2009). Traumatic
brain injury and long-term quality of life: findings from an
Australian study. J. Neurotrauma 26, 16231633.
Hays, R.D., Hayashi, T., Carson, S., and Ware Jr., J.E. (1988).
Users Guide for the Multitrait Analysis Program. RAND Corporation: Santa Monica, CA.
Hu, L., and Bentler, P.M. (1999). Cutoff criteria for fit indexes in
covariance structure analysis: Conventional criteria versus
new alternatives. Structural Equation Modeling 6, 155.
Jennet, B., and Bond, M. (1975). Assessment of outcome after
severe brain damage. Lancet, 480484.
Klonoff, P.S., Costa, L.D., and Snow, W.G. (1986). Predictors and
indicators of quality of life in patients with closed-head injury.
J. Clin. Exp. Neuropsych. 8, 469485.
Klonoff, P.S., Watt, L.M., Dawson, L.K., Henderson, S.W.,
Gehrels, J.-A., and Voreis Wethe, J. (2006). Psychosocial
outcomes 17 years after comprehensive milieu-oriented
neurorehabilitation: The role of pre-injury status. Brain Inj.
20, 601612.
Koskinen, S. (1998). Quality of life 10 years after a very severe
traumatic brain injury (TBI): The perspective of the injured
and the closest relative. Brain Inj. 12, 631648.
Lippert-Gruner, M., Maegele, M., Haverkamp, H., Klug, N., and
Wedekind, C. (2007). Health-related quality of life during the
first year after severe brain trauma with and without polytrauma. Brain Inj. 21, 451455.
MacKenzie, E.J., McCarthy, M.L., Ditunno, J.F., Forrester-Staz,
C., Gruen, G.S., Marion, D.W., and Schwab, W.C. (2002).
Using the SF-36 for characterizing outcome after multiple
trauma involving head injury. J. Trauma 52, 527534.
Mascialino, G., Hirshson, C., Egan, M., Cantor, J., Ashman, T.,
Tsaousides, T., and Spielman, L. (2009). Objective and subjective assessment of long-term community integration in
minority groups following traumatic brain injury. NeuroRehabilitation 24, 2936.
McCrimmon, S. and Oddy, M. (2006). Return to work following
moderate-to-severe traumatic brain injury. Brain Inj. 20, 1037
1046.
McCarthy, M.L., Dikmen, S., Langlois, J.A., Selassie, A.W., Gu
J.K., and Horner, M.D. (2006). Self-reported psychosocial
health among adults with traumatic brain injury. Arch. Phys.
Med. Rehabil. 87, 953961.
Moosbrugger, H., and Kelava, A. (2007). Testtheorie und Fragebogenkonstruktion (Test theory and questionnaire construction).
Springer: Berlin.
Neugebauer, E., Bouillon, B., Bullinger, M., and Wood-Dauphinee, S. (2002). Quality of life after multiple traumaSummary
1182
and recommendations of the consensus conference. Restor.
Neurol. Neurosci. 20, 161167.
NIH Consensus Development Panel on Rehabilitation of Persons
with Traumatic Brain Injury (1999). Rehabilitation of persons
with traumatic brain injury. JAMA 282, 974983.
Novella, J.L., Jochum, C., Ankri, J., Morrone, I., Jolly, D., and
Blanchard, F. (2001). Measuring general health status in dementia: practical and methodological issues in using the SF-36.
Aging (Milano) 13, 362369.
Olsson, I., Mykletun, A., and Dahl, A.A. (2005). The Hospital
Anxiety and Depression Rating Scale: A cross-sectional study
of psychometrics and case finding abilities in general practice.
BMC Psychiatry 14, 46.
Pagulayan, K.F., Hoffmann, J.M., Temkin, N.R., Machamer, J.E.,
and Dikmen, S.S. (2008). Functional limitations and depression after traumatic brain injury: Examination of the temporal
relationship. Arch. Phys. Med. Rehabil. 89, 18871892.
Papulayan, K.F., Temkin, N.R., Machamer, J., and Dikmen, S.S.
(2006). A longitudinal study of health-related quality of life
after traumatic brain injury. Arch. Phys. Med. Rehabil. 87,
611618.
Pierce, C.A., and Hanks, R.A. (2006). Life satisfaction after
traumatic brain injury and the World Health Organisation
model of disability. Am. J. Phys. Med. Rehabil. 85, 889898.
Powell, J.H., Beckers, K., and Greenwood, R.J. (1998). Measuring
progress and outcome in community rehabilitation after brain
injury with a new assessment instrumentthe BICRO-39
Scales. Arch. Phys. Med. Rehab. 79, 12131225.
Power, M., Quinn, K., Schmidt, S., and the WHOQOL-OLD
Group. (2005). Development of the WHOQOL-old module.
Qual. Life. Res. 14, 21972214.
Riemsma, R.P., Forbes, C.A., Glanville, J.M., Eastwood, A.J., and
Kleijnen, J. (2001). General health status measures for people
with cognitive impairment: Learning disability and acquired
brain injury. Health Technol. Assess. 5, 1100.
Rimel, R.W., Giordani, B., Barth, J.T., and Jane, J.A. (1982).
Moderate head injury: completing the clinical spectrum of
brain trauma. Neurosurgery 11, 344351.
Schonberger, M., Humle, F., Zeemann, P., and Teasdale, T.W.
(2006). Working alliance and patient compliance in brain injury rehabilitation and their relation to psychosocial outcome.
Neuropsychol. Rehab. 16, 298314.
Shames, J., Treger, I., Ring, H., and Giaquinto, S. (2007). Return
to work following traumatic brain injury: Trends and challenges. Disabil. Rehabil. 29, 13871395.
Schmidt, S., Debensason, D., Muhlan, H., Petersen, C., Power,
M., Simeoni, M., and Bullinger, M. (2006). The DISABKIDS
generic quality of life instrument showed cross-cultural validity. J. Clin. Epidemiol. 29, 587598
Smith, A.B., Rush, R., Fallowfield, L.J., Velikova, G., and Sharpe,
M. (2008). Rasch Fit Statistics and Sample Size Considerations
for Polytomous Data. BMC Med. Res. Methodol. 8, 33.
Sopena, S., Dewar, B.K., Nannery, R., Teasdale, T.W., and Wilson, B.A. (2007). The European Brain Injury Questionnaire
(EBIQ) as a reliable outcome measure for use with people with
brain injury. Brain Inj. 21, 10631068.
Stucki, G., Stucki, S., and Sangha, O. (1997). Patientenzentrierte
Evaluation der Krankheitsauswirkungen bei musculoskeletalen Erkrankungen. Adaptation und Neuentwicklung von
Outcome Instrumenten. Z. Rheumatologie 56, 266275.
Teasdale, G., and Jennett, B. (1974). Assessment of coma and
impaired consciousness. A practical scale. Lancet 2, 8184.
Teasdale, T.W., Christensen, A., Willmes, K., Deloche, G., Braga,
L., Stachowiak, F., Vendrell, J.M., Castro-Caldas, A., Laakso-
CHEL ET AL.
VON STEINBU
nen, R., and Leclercq, M. (1997). Subjective experience in
brain-injured patients and their close relatives: a European
Brain Injury Questionnaire study. Brain Inj. 11, 543563.
Tomberg, T., Toomela, A., Pulver, A., and Tikki, A. (2005).
Coping strategies, social support, life orientation and healthrelated quality of life following traumatic brain injury. Brain
Inj. 19, 11811190.
Tazopoulou, E., Truelle, J.-L., North, P., and Montreuil, M.
(2005). Generic and specific measures of quality of life after
traumatic brain injury: Initial validation of a new specific
measure, The QOLBI. Acta Neuropsychol. 3, 1324.
Truelle, J.-L., von Wild, K., Hofer, S., Neugebauer, E., Lischetzke,
T., von Steinbuchel, N., and the QOLIBRI Group (2008). The
QOLIBRITowards a quality of life tool after traumatic brain
injury: Current developments in Asia. Acta Neurochir. Suppl.
101, 125129.
von Steinbuchel, N. (1995). Gesundheitsbezogene Lebensqualitat
als Beurteilungskriterium fur Behandlungseffekte bei Patienten mit Epilepsie. Pravention Rehabilitation 7, 39146.
von Steinbuchel N., Lischetzke T., Gurny M., and Eid, M. (2006)
Assessing quality of life in older people: psychometric properties of WHOQOL-BREF. Eur. J. Ageing 3, 116122.
von Steinbuchel, N., Petersen, C., and Bullinger, M. (2002). Study
protocol, cognitive debriefing protocol and harmonization
guidelines for the QOLIBRI Development in TBI study. Unpublished.
von Steinbuchel, N., Petersen, C., Bullinger, M., and the QOLIBRI Group. (2005b). Assessment of Health-related quality
of life in persons after traumatic brain injuryDevelopment
of the QOLIBRI, a specific measure. Acta Neurochir. 93, 4349.
von Steinbuchel, N., Richter, S., Morawetz, C., and Riemsma, R.
(2005a). Assessment of subjective health and health-related
quality of life in persons with acquired or degenerative brain
injury. Curr. Opin. Neurol. 18, 681691.
von Steinbuchel, N., Wilson, L., Gibbons, H., Hawthorne, G.,
Hofer, S., Schmidt, S., Bullinger, M., Maas, A., Neugebauer, E.,
Powell, J., von Wild, K., Zitnay, G., Bakx, W., Christensen, A.L., Koskinen, S., Formisano, R., Jana Saarajuri, J., Sasse, N.,
Truelle J.-L., and the QOLIBRI Task Force (2010). Quality of
Life after Brain Injury (QOLIBRI)scale validity and correlates of quality of life. J. Neurotrauma 27, 11571165.
Ware, J.E., and Kosinski, M. (1996). The SF-36 Health Survey
(Version 2.0) Technical Note. Health Assessment Lab: Boston,
September 20.
Ware, J.E., Keller, S.D., Gandek, B., Brazier, J., and Sullivan, M.
(1995). Evaluating translations of the health status questionnaires. Methods from the IQOLA project. Int. J. Technol. Assess. Health Care 11, 525551.
Ware, J.E. (2000). SF-36 Health Survey Update. Spine 25, 3130
3139.
Ware, J.E., Snow, K.K., Kosinski, M., and Gandek, B. (1993). SF36 Health Survey Manual and Interpretation Guide. New England
Medical Center, The Health Institute: Boston.
WHOQOL group. (1998). The World Health Organization
Quality of Life Assessment (WHOQOL): development and
general psychometric properties. Soc Sci. Med. 46, 15691585.
Wilson, L., Pettigrew, L., and Teasdale, G. (1998). Structured
interviews for the Glasgow Outcome Scale and the Extended
Glasgow Outcome Scale: Guidelines for their use. J. Neurotrauma 15, 573585.
Wlodarczyk, J.H., Brodathy, H., and Hawthorne, G. (2004). The
relationship between quality of life, Mini-Mental State Examination, and the Instrumental Activities of Daily Living in patients
with Alzheimers Disease. Arch. Gerontol. Geriat. 39, 2533.
1183
Address correspondence to:
Nicole von Steinbuchel, Ph.D.
Department of Medical Psychology and Medical Sociology
Georg-August-University
Waldweg 37
Goettingen, Germany
E-mail: nvsteinbuechel@med.uni-goettingen.de
(Appendix follows)
CHEL ET AL.
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Appendix: QOLIBRIQuality of Life After Brain Injury
In the first part of this questionnaire we would like to know how satisfied you are with different aspects of your life since your
brain injury. For each question please choose the answer which is closest to how you feel now (including the past week) and
mark the box with an X. If you have problems filling out the questionnaire, please ask for help.
PART 1
A. These questions are about your thinking
abilities now (including the past week).
Not at all
Slightly
Moderately
Quite
Very
Not
at all
B. These questions are about your emotions and view of yourself now
(including the past week).
1.
2.
3.
4.
5.
6.
7.
How
How
How
How
How
How
How
satisfied
satisfied
satisfied
satisfied
satisfied
satisfied
satisfied
are
are
are
are
are
are
are
you
you
you
you
you
you
you
with
with
with
with
with
with
with
Slightly
Moderately
Quite
Very
C. These questions are about your independence and how you function
in daily life now (including the past week).
Not
at all
Slightly
Moderately
Quite
Very
Moderately
Quite
Very
1. How satisfied are you with the extent of your independence from others?
2. How satisfied are you with your ability to get out and about?
3. How satisfied are you with your ability to carry out domestic activities,
for example cooking or repairing things?
4. How satisfied are you with your ability to run your personal finances?
5. How satisfied are you with your participation in work or education?
6. How satisfied are you with your participation in social and leisure
activities, for example sports, hobbies, parties?
7. How satisfied are you with the extent to which you are in charge
of your own life?
Not
at all
Slightly
1185
PART 2
In the second part we would like to know how bothered you feel by different problems. For each question please choose the
answer which is closest to how you feel now (including the past week), and mark the box with an X. If you have problems
filling out the questionnaire, please ask for help.
E. These questions are about how bothered you are by your feelings now
(including the past week).
1. How bothered are you
are with other people?
2. How bothered are you
3. How bothered are you
4. How bothered are you
5. How bothered are you
Not
at all
Slightly
Moderately
Quite
Very
feeling
feeling
feeling
feeling
bored?
anxious?
sad or depressed?
angry or aggressive?
F. These questions are about how bothered you are by physical problems now
(including the past week).
1. How bothered are you by slowness and/or clumsiness
of movement?
2. How bothered are you by effects of any other injuries
you sustained at the same time as your brain injury?
3. How bothered are you by pain, including headaches?
4. How bothered are you by problems with seeing
or hearing?
5. Overall, how bothered are you by the effects
of your brain injury?
The authors of this article, all rights reserved,
www.qolibrinet.com.
For details contact nvsteinbuechel@med.uni-goettingen.de.
Not
at all
Slightly
Moderately
Quite
Very