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The Knee Injury and Osteoarthritis Outcome Score (KOOS) was constructed in Sweden. This questionnaire has proved to be valid for several orthopedic interventions of the knee. It has been formally translated and validated in several languages, but not yet in Dutch. The purpose of the present study was to evaluate the clinimetric properties of the Dutch version of the KOOS questionnaire in knee patients with various stages of osteoarthritis (OA). The Swedish version of the KOOS questionnaire was first translated into Dutch according to a standardized procedure and second tested for clinimetric quality. The study population consisted of patients with different stages of OA (mild, moderate and severe) and of patients after primary TKA, and after a revision of the TKA. All patients filled in the Dutch KOOS questionnaire, as well as the SF-36 and a Visual Analogue Scale for pain. The following analyses were performed to evaluate the clinimetric quality of the KOOS: Cronbach's alpha (internal consistency), principal component analyses (factor analysis), intraclass correlation coefficients (reliability), spearman's correlation coefficient (construct validity), and floor and ceiling effects. For all patients groups Cronbach's alpha was for all subscales above 0.70. The ICCs, assessed for the patient groups with mild and moderate OA and after revision of the TKA patients, were above 0.70 for all subscales. Of the predefined hypotheses 60% or more could be confirmed for the patients with mild and moderate OA and for the TKA patients. For the other patient groups less than 45% could be confirmed. Ceiling effects were present in the mild OA group for the subscales Pain, Symptoms and ADL and for the subscale Sport/Recreation in the severe OA group. Floor effects were found for the subscales Sport/Recreation and Qol in the severe OA and revision TKA groups. Based on these different clinimetric properties within the present study we conclude that the KOOS questionnaire seems to be suitable for patients with mild and moderate OA and for patients with a primary TKA. The Dutch version of the KOOS had a lower construct validity for patients with severe OA on a waiting list for TKA and patients after revision of a TKA. Further validation studies on the Dutch version of the KOOS should also include a knee specific questionnaire for assessing the construct validity.
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BioMed Central
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Health and Quality of Life Outcomes
Open Access
Research
The Dutch version of the knee injury and osteoarthritis outcome
score: A validation study
Ingrid B de Groot*
1
, Marein M Favejee
1
, Max Reijman
1
, Jan AN Verhaar
1
and
Caroline B Terwee
2
Address:
1
Department of Orthopaedics, Erasmus University Medical Center, Rotterdam, The Netherlands and
2
EMGO Institute, VU University
Medical Center, Amsterdam, The Netherlands
Email: Ingrid B de Groot* - i.b.degroot@erasmusmc.nl; Marein M Favejee - m.favejee@erasmusmc.nl; Max Reijman - m.reijman@erasmusmc.nl;
Jan AN Verhaar - j.verhaar@erasmusmc.nl; Caroline B Terwee - cb.terwee@vumc.nl
* Corresponding author
Abstract
Background: The Knee Injury and Osteoarthritis Outcome Score (KOOS) was constructed in Sweden.
This questionnaire has proved to be valid for several orthopedic interventions of the knee. It has been
formally translated and validated in several languages, but not yet in Dutch. The purpose of the present
study was to evaluate the clinimetric properties of the Dutch version of the KOOS questionnaire in knee
patients with various stages of osteoarthritis (OA).
Methods: The Swedish version of the KOOS questionnaire was first translated into Dutch according to
a standardized procedure and second tested for clinimetric quality. The study population consisted of
patients with different stages of OA (mild, moderate and severe) and of patients after primary TKA, and
after a revision of the TKA. All patients filled in the Dutch KOOS questionnaire, as well as the SF-36 and
a Visual Analogue Scale for pain. The following analyses were performed to evaluate the clinimetric quality
of the KOOS: Cronbach's alpha (internal consistency), principal component analyses (factor analysis),
intraclass correlation coefficients (reliability), spearman's correlation coefficient (construct validity), and
floor and ceiling effects.
Results: For all patients groups Cronbach's alpha was for all subscales above 0.70. The ICCs, assessed for
the patient groups with mild and moderate OA and after revision of the TKA patients, were above 0.70
for all subscales. Of the predefined hypotheses 60% or more could be confirmed for the patients with mild
and moderate OA and for the TKA patients. For the other patient groups less than 45% could be
confirmed. Ceiling effects were present in the mild OA group for the subscales Pain, Symptoms and ADL
and for the subscale Sport/Recreation in the severe OA group. Floor effects were found for the subscales
Sport/Recreation and Qol in the severe OA and revision TKA groups.
Conclusion: Based on these different clinimetric properties within the present study we conclude that
the KOOS questionnaire seems to be suitable for patients with mild and moderate OA and for patients
with a primary TKA. The Dutch version of the KOOS had a lower construct validity for patients with
severe OA on a waiting list for TKA and patients after revision of a TKA. Further validation studies on the
Dutch version of the KOOS should also include a knee specific questionnaire for assessing the construct
validity.
Published: 26 February 2008
Health and Quality of Life Outcomes 2008, 6:16 doi:10.1186/1477-7525-6-16
Received: 2 August 2007
Accepted: 26 February 2008
This article is available from: http://www.hqlo.com/content/6/1/16
© 2008 de Groot et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0
),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Health and Quality of Life Outcomes 2008, 6:16 http://www.hqlo.com/content/6/1/16
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Introduction
There is consensus that patient-reported outcomes have
additional value to clinical variables to evaluate patients'
health. The underlying principle is that functional status
and quality of life can better be described by the patients
themselves than by a physician [1]. With regards to knee
surgery, however, at the start of the present study almost
no reliable and validated Dutch versions of disease-spe-
cific questionnaires were available to evaluate the func-
tional status of patients and quality of life after surgery.
The Western Ontario and McMaster Universities Osteoar-
thritis Index (WOMAC) is recommended for the assess-
ment of treatment effects in patients with osteoarthritis
(OA) and was developed for elderly with OA and assesses
pain, stiffness and function in daily living [2-4].
Traumatic knee injuries often cause damage to structures
such as ligaments, menisci and cartilage, and may lead to
early development of OA. To be able to follow patients
after a trauma and to monitor the changes in functional
status and quality of life over time, a questionnaire is
needed which covers both the short and long-term conse-
quences of an injury of the knee [5]. In other words, there
is a clear need for an instrument that not only monitors
the outcome in elderly knee OA patients, but also moni-
tors the consequences of acute knee injury in physically
active patients in their early adulthood.
Therefore, Roos et al. developed such a questionnaire in
Sweden [6,7]. The Knee Injury and Osteoarthritis Out-
come Score (KOOS) evaluates the functional status and
quality of life of patients with any type of knee injury who
are at increased risk to develop OA; i.e. patients with ante-
rior cruciate ligament (ACL) injury, meniscus injury or
chondral injury. Until now, the KOOS questionnaire has
been validated for several orthopedic interventions such
as ACL reconstruction [7], total knee arthroplasty (TKA)
[8], and menisectomy [9]. It has been formally translated
and validated in several languages, but not yet in Dutch.
The purpose of this study was therefore to translate the
KOOS questionnaire into Dutch and to evaluate the clin-
imetric properties of the Dutch version of the KOOS ques-
tionnaire, in terms of internal consistency, reliability,
validity, and floor and ceiling effects.
We studied the Dutch version of the KOOS in patients
with different stages of OA: mild, moderate and severe OA
and in patients after a primary TKA and after revision of
the TKA.
Methods
The study was divided into two stages. First, the Swedish
version of the KOOS questionnaire was translated into
Dutch according to a standardized procedure [10]. Sec-
ond, the translated version was tested for clinimetric qual-
ity in a prospective study.
Procedure of translation
The procedure of translation included three steps [11].
First two persons (T1 and T2) translated independently of
each other the Swedish version of the KOOS question-
naire into Dutch (forward translation); one translator had
a technical background and the other had a medical back-
ground; both were native Dutch speakers. Based on a con-
sensus meeting one final version (T-12) was formed [10].
Second, two bilingual persons (T3 and T4), one with a
background in education and the other with a chemical
background, both native Swedish speakers, independ-
ently re-translated this Dutch version (T-12) into Swedish
(backward translation). They were blind to the original
Swedish version.
Finally, all translators had a consensus meeting to consol-
idate the final version of the Dutch version of the KOOS
questionnaire, which was used in the present study. This
final version was presented to a subset of 15 patients suf-
fering from knee complaints. These patients were asked
whether they understood all items and whether they had
any problems with the formulation of the items on the
Dutch version of the KOOS questionnaire. None of the
patients reported problems with the items of the KOOS
questionnaire.
Patients
We used five patient groups with different stages of OA of
the knee of the knee, based on clinical and radiographic
signs, to evaluate the clinimetric properties of the Dutch
version of the KOOS questionnaire. All patients were
under medical treatment at the department of Orthoped-
ics at the Erasmus Medical Center in Rotterdam between
1990 and 2005.
The first patient group consisted of patients with mild OA,
who had undergone ACL reconstruction between 1994
and 1996. The second patient group consisted of patients
with moderate OA who had undergone HTO between
1998 and 2000. All patients in this group had a valgus cor-
rection within a range of 5 to 14 degrees. The third patient
group consisted of patients with severe OA who were on
the waiting list for a TKA. The fourth patient group con-
sisted of patients 6 months after a TKA, who were oper-
ated between 2004 and 2006. The fifth patient group
consisted of patients who had undergone a revision of the
primary TKA because of a failure of the primary TKA
between 2001 and 2006. Patients unable to understand
Dutch written language were excluded. The Medical Ethics
Committee at the Erasmus Medical Center approved all
studies. The choice of our study population, except for the
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TKA population, was based on existing retrospective
cohort studies.
All participants were asked to complete three question-
naires at home: the Dutch KOOS, the SF-36 [12], and a
Visual Analogue Scale for pain [13] between June 2004
and July 2006. They were asked to fill in the Dutch KOOS
at home again after two till three weeks. For test-retest
studies the time interval needs to be sufficiently short to
support the assumption that the patients remain stable
and to be sufficiently long to prevent recall [14]. We con-
sidered a time interval of three weeks to be appropriate for
these patient populations. The local Medical Ethics Com-
mittee approved the study and all participants gave their
written informed consent.
Questionnaires
KOOS
The KOOS questionnaire covers five dimensions that are
reported separately: Pain (nine items), Symptoms (seven
items), activities of daily living (ADL, 17 items), sport and
function (Sport/recreation, five items), and knee-related
quality of life (QoL, four items). Standardized answer
options are provided and each question is rated on a scale
from 0 to 4. A normalized score (100 indicating no symp-
toms and 0 indicating extreme symptoms) is then calcu-
lated for each subscale. The format is user-friendly and the
questionnaire takes about 10 minutes to complete. The
KOOS questionnaire is self-explanatory and can be
administrated in the waiting room or used as a mailed sur-
vey [7]. The KOOS questionnaire includes the WOMAC
Osteoarthritis Index LK 3.0 [2,3] in its complete and orig-
inal format (with permission), and WOMAC scores can be
calculated. The WOMAC is worldwide used in elderly sub-
jects with knee or hip OA [2]. The Dutch version of the
WOMAC is validated for hip OA patients [15].
Short Form-36 (SF-36)
The SF-36 is a generic health status questionnaire that
contains 36 items. It measures eight dimensions (bodily
pain; physical function; social function; role limitations
because of physical problems; role limitations because of
emotional problems; mental health; vitality; general
health perceptions) and is widely used, has shown to be
reliable and valid in the Dutch general population, and is
easy to complete [1,16].
Visual analogue scale for pain
The Visual Analogue Scale (VAS) for pain is a simple way
of measuring the intensity of pain. The 100-mm VAS is a
unidimensional scale that is versatile, easy to use, and has
been adopted in many settings. It has shown to be valid
and reliable [13].
Statistical analysis
Internal consistency
A high degree of homogeneity is desirable in a scale. This
has two implications: 1) the items should be at least mod-
erately correlated with each other, and 2) each item
should correlate above 0.20 with the total scale score [14].
These two factors form the basis of the various tests of
homogeneity or internal consistency of the scale. The
internal consistency was determined by calculating Cron-
bach's alpha. The widely accepted cut-off is that Cron-
bach's alpha should be 0.70 or higher for a set of items to
be considered a (sub) scale [14,17].
Factor analysis
Factor analysis is a technique designed to reveal whether
or not the pattern of responses on a number of tests can
be explained by a smaller number of underlying traits or
factors, with each factor reflecting a different construct
[14]. Streiner et al. noted that an absolute minimum of
five subjects per variable is necessary, with the proviso
that there are at least 100 subjects. Exploratory factor anal-
yses were conducted on all KOOS items using principal
component analyses (PCA) with varimax rotation on the
combined study population, because all subgroups had a
number lower than 100. We first extracted factors with
eigenvalues greater than 1. Next, we carried out a forced
five, four, three, two and one factor solution.
First, we identified the number of meaningful factors
based on the Scree plot and on the interpretation of the
factor solutions. Using the Scree plot, we looked for a
break between the factors with relatively large eigenvalues
and those with smaller eigenvalues. Factors that appeared
before the break were assumed to be meaningful, and fac-
tors that appeared on the approximately horizontal line
after the break were considered to account for only a triv-
ial amount of variance and were therefore not considered
meaningful. Second, we looked at the factor structure and
factor loadings after varimax rotation. Items with a factor
loading less than 0.50 on all factors could be considered
for exclusion. In other words factor analysis was per-
formed in order to determine whether the KOOS ques-
tionnaire actually consists of 5 subscales.
Reliability
Reliability involves the degree to which the results of
measurement are consistent across repeated measure-
ments [14]. To estimate the test-retest reliability of the
Dutch KOOS subscales, we calculated intraclass correla-
tion coefficients (ICCs) with a 95% confidence interval
(95% CI). Due to practical problems we only assed the
test-retest reliability at the mild and moderate OA group
and the revision TKA group. We used the ICC two-way
random effects model type agreement to measure the reli-
ability [18]. The ICC is generally considered to be good at
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0.70 and above [14]. The standard error of measurement
(SEM) is a measure of the absolute measurement error of
a score, expressed in the unit of measurement of the
instrument [19]. The SEM was calculated as the square
root of the sum of the between administration variance
and the residual variance [20].
Validity
Validity is the degree to which an instrument measures the
construct it is intended to measure. Because of the absence
of a gold standard the validity was expressed in terms of
construct validity, which concerns the extent to which a
particular measure relates to other measures consistent
with theoretically derived hypotheses for the constructs
that are being measured [21]. The construct validity of the
KOOS questionnaire was determined by comparing its
results with the generic SF-36 and the VAS for pain.
Hypotheses were formulated about the expected magni-
tude and direction of relationships between the subscales
of the KOOS questionnaire and the other instruments.
The formulation of the hypotheses was based on the start-
ing point that there is a clear distinction between the sub-
scales of the KOOS questionnaire. We defined the
construct validity of the KOOS questionnaire as good if
75% of the hypotheses could be confirmed [22], moder-
ate in case of 50–75% confirmation, and low when under
50% of confirmation. To evaluate the construct validity of
the Dutch KOOS version, Spearman's correlations were
calculated.
We formulated four hypotheses about convergent rela-
tions between the KOOS questionnaire, SF-36 and VAS for
pain. The correlation between KOOS Pain and SF-36 BP,
between KOOS Pain and SF-36 PF, KOOS (all subscales)
and VAS for Pain and KOOS ADL and SF-36 PF should be
0.60. We expected that KOOS Pain has a stronger corre-
lation with SF-36 BP compared to the correlation with SF-
36 PF. This difference should be at least 0.05 higher. We
further expected that KOOS Pain has a stronger correla-
tion with VAS for pain compared to the correlation of the
other subscales of the KOOS with the VAS for Pain. This
difference should be at least 0.05 higher. KOOS ADL was
expected to have a 0.05 higher correlation with SF-36 PF
compared to the correlation of the other subscales of the
SF-36.
We formulated five hypotheses about divergent relations
between all subscales of the KOOS questionnaire and SF-
36 GH: with correlations of 0.30. All other correlations
between the KOOS subscales and the SF-36 should be
higher than 0.30 and lower than 0.60.
Floor and ceiling effects
The presence of floor and ceiling effects may influence the
reliability, validity and responsiveness of an instrument.
An intervention effect might be missed for people who
occupy the maximum score. Floor and ceiling effects were
considered present if more than 15% of the respondents
achieved the highest or lowest possible score [22].
Data were analysed with SPSS statistical software version
10.1. The level of significance for all statistical procedures
was p 0.05.
Results
Table 1 presents the characteristics of five patient groups.
The first patient group consisted of 36 patients with mild
OA (response rate of 79%). All patients filled in the ques-
tionnaires for the cross-sectional validity. For the test-
retest reliability 35 patients filled in the KOOS question-
naire twice. The second patient group consisted of 62
patients with moderate OA (response rate of 76%) who
filled in the questionnaires for the cross-sectional validity.
Of these patients 53 filled in the KOOS questionnaire
twice for the test-retest reliability. The third patient group
consisted of 47 patients with severe OA (response rate of
54%). The fourth group consisted of 63 TKA patients
(response rate of 77%) and the fifth group of 54 patients
with a revision of the TKA (response rate of 75%). These
patients filled in all questionnaires for the cross-sectional
validity and 47 patients filled in the KOOS questionnaire
twice for the test-retest reliability.
Internal consistency
Table 2 presents the internal consistency expressed by
Cronbach's alpha. For all patients groups Cronbach's
alpha was for all subscales above 0.71, indicating a good
internal consistency of all items in these scales and sub-
scales. Except for the subscale Symptoms in the severe OA
group a Cronbach's alpha of 0.56 was found, which indi-
cates a moderate internal consistency.
Factor analysis
The Scree plot showed a distinct break before factor 3, sug-
gesting that only the first two factors were meaningful
enough to be retained. This indicates that two factors may
be adequate to describe the data. This initial solution
accounted for 64% of the total variance for the Dutch ver-
sion of the KOOS questionnaire (eigenvalue of 21.5 for
the first factor and 3.7 for the second factor). However, in
the two-factor solution, many items loaded on both fac-
tors. Therefore, we chose a forced one-factor solution,
which accounted for 51.0% of the variance. The loading
factors ranged from 0.37 – 0.85. The loading factor of the
question S4 was lower than 0.40.
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Reliability
Table 3 presents the ICCs of all subscales of the KOOS
questionnaire for patient groups with mild and moderate
OA and after revision of the TKA patients. In these patient
groups the ICCs were 0.70 or higher, indicating a good
reliability. Only an ICC of 0.45 was found for the subscale
Sport/recreation in the revision TKA group.
The SEM ranged for the mild OA group between 5.2 and
9.0, for the moderate OA group between 5.8 and 11.6 and
for patients after revision of the TKA between 7.2 and
24.6.
Validity
Of the predefined hypotheses 60% or more could be con-
firmed for the study groups with mild OA and moderate
OA and for the TKA patient population. For the severe OA
group and the revision TKA group less than 45% could be
confirmed. Tables 4, 5, 6, 7 and 8 show the correlations
between the KOOS subscales, the SF-36 subscales and the
VAS for pain. Overall, the highest correlations between
the KOOS subscales and the SF-36 bodily pain and phys-
ical function were found. Correlations between the KOOS
subscale Pain and the VAS-pain were between r = -0.28
and -0.79.
Floor and ceiling effects
Neither floor effects (indicating worst possible score) nor
ceiling effects (indicating best possible score) were found
for the patients with moderate OA patients and the TKA
patients (Table 9). Only ceiling effects were present in the
mild OA group for the subscales Pain, Symptoms and
ADL and for the subscale Sport/Recreation in the severe
OA TKA group. Floor effects were found for the subscales
Sport/Recreation and Qol in the severe OA and revision
TKA.
Table 1: Characteristics of the five patient groups
Mild OA (n = 36) Moderate OA (n = 62) Severe OA (n = 47) TKA (n = 63) Revision of TKA (n = 54)
Age in years 36 (27–50) 56 (27–72) 65 (42–81) 61(42–78) 77 (36–89)
Gender, women % 22 32 52 51 78
VAS pain 0.7 (0.0–6.7) 3.9 (0.0–10.0) 6.1 (1.0–10.0) 1 (0.0–9.4) 5.0 (0–10)
KOOS
Pain 85.3 ± 18.5 62.9 ± 25.7 41.8 ± 18.9 70.1 ± 24.5 61.6 ± 23.4
Symptoms 78.6 ± 7.1 63.2 ± 24.4 46.4 ± 18.7 72.3 ± 18.5 64.7 ± 21.5
ADL 91.2 ± 15.1 69.3 ± 24.2 43.4 ± 19.4 72.8 ± 23.3 56.6 ± 21.9
Sport/recreation 71.0 ± 23.4 36.2 ± 32.0 29.1 ± 39.2 33.2 ± 24.1 26.8 ± 34.1
QoL 67.0 ± 21.6 44.6 ± 26.3 30.9 ± 25.5 52.2 ± 23.8 36.6 ± 26.6
SF-36
BP 84.7 ± 19.7 63.6 ± 24.0 34.6 ± 22.1 70.7 ± 24.9 55.4 ± 27.2
PF 86.4 ± 17.2 61.1 ± 24.8 34.9 ± 20.6 61.7 ± 23.9 32.9 ± 24.4
SF 92.4 ± 10.5 82.8 ± 21.9 61.7 ± 28.1 81.8 ± 28.6 64.1 ± 29.0
RF 77.8 ± 38.2 64.8 ± 39.7 26.6 ± 34.7 57.4 ± 43.7 31.0 ± 38.8
RE 91.7 ± 25.7 87.4 ± 28.5 57.4 ± 44.3 69.7 ± 43.6 59.9 ± 42.6
MH 86.8 ± 13.4 79.6 ± 19.2 69.1 ± 20.0 74.6 ± 21.7 70.3 ± 20.7
VT 75.4 ± 13.4 68.9 ± 19.3 53.9 ± 19.3 66.5 ± 21.8 55.5 ± 19.1
GH 84.0 ± 12.8 65.0 ± 20.8 60.2 ± 23.0 66.8 ± 24.1 51.4 ± 21.3
Results are presented as median (range) or mean ± SD. Abbreviations: OA; osteoarthritis, TKA; total knee arthroplasty, Revision of TKA; Revision
of total knee arthroplasty; VAS, Visual Analogue Scale; BP, bodily pain; PF, physical function; SF, social function; RF, role limitations because of
physical problems; RE, role limitations because of emotional problems; MH, mental health; VT, vitality; GH, general health perception; ADL,
Activities of daily living; QoL, Quality of life.
Table 2: Internal consistency of the KOOS subscales, expressed by Cronbach's alpha
KOOS subscales Mild OA Moderate OA Severe OA TKA Revision of TKA
Pain (9 items) 0.94 0.93 0.80 0.92 0.87
Symptoms (7 items) 0.71 0.83 0.56 0.74 0.78
ADL (17 items) 0.78 0.97 0.94 0.94 0.93
Sport/Recreation (5 items) 0.87 0.95 0.98 0.88 0.95
QoL (4 items) 0.81 0.85 0.73 0.81 0.90
Abbreviations: OA; osteoarthritis, TKA; total knee arthroplasty, Revision of TKA; Revision of total knee arthroplasty, ADL, Activities of daily living;
QoL; Quality of life.
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Discussion
The results of this validation study of the Dutch KOOS
questionnaire showed a good internal consistency for all
study groups. Reliability was also good in the mild and
moderate OA group and the revision TKA group. It was
not assessed the patients with severe OA and patients with
a TKA. The construct validity was moderate for the patient
groups with mild and moderate OA and for TKA patients,
and lower for the severe OA and revision TKA patients.
Ceiling effects were present in the mild OA group and in
the severe OA group. Floor effects were seen in the patient
group with severe OA group and the revision TKA group.
In this validation study Cronbach's alphas were above
0.70 for almost all subscales in our patient groups. This
indicates a good internal consistency, which is in line with
the study of Roos et al. [6,8]. However, for the subscale
Symptoms in the severe OA population we found a Cron-
bach's of 0.56, indicating a moderate internal consistency.
Deleting one or more questions did not result in a higher
internal consistency. Kessler et al. and Xie et al. also found
a lower Cronbach's alpha (< 0.70) for this subscale in
patients with OA of the knee [23,24].
Table 3: Reliability of all subscales of the KOOS
Baseline
mean (SD)
Retest
mean (SD)
Change scores
mean (SD)
SEM ICC agreement 95% CI
Mild OA (n = 35) Pain 85.3 (18.5) 89.7 (12.5) -4.4 (9.4) 7.2 0.80 0.60–0.90
Symptoms 78.6 (7.1) 81.3 (16.8) -2.2 (12.8) 9.0 0.74 0.54–0.86
ADL 91.2 (15.1) 93.5 (10.8) -2.3 (7.1) 5.2 0.85 0.71–0.92
Sport/recreation 71.0 (23.4) 73.0 (22.9) -1.7 (12.8) 9.0 0.85 0.73–0.92
QoL 67.0 (21.6) 69.6 (20.5) -2.5 (10.3) 7.4 0.88 0.77–0.94
Moderate OA (n
= 53)
Pain 62.9 (25.7) 63.2 (23.7) 0.0 (12.9) 9.0 0.87 0.78–0.92
Symptoms 63.2 (24.4) 66.2 (21.9) -1.5 (11.3) 8.0 0.87 0.79–0.92
ADL 69.3 (24.2) 69.2 (23.7) 0.6 (8.2) 5.8 0.94 0.90–0.97
Sport/recreation 36.2 (32.0) 39.7 (32.5) -4.8 (15.9) 11.6 0.87 0.78–0.92
QoL 44.6 (26.3) 47.3 (25.4) -2.1 (10.3) 7.4 0.91 0.86–0.95
Revision of TKA
(n = 47)
Pain 61.6 (23.4) 63.9 (21.9) -2.3 (14.3) 10.1 0.80 0.67–0.88
Symptoms 64.7 (21.5) 62.9 (21.7) 1.7 (10.2) 7.2 0.89 0.81–0.94
ADL 56.6 (21.9) 59.5 (22.9) -2.9 (16.4) 11.7 0.73 0.56–0.83
Sport/recreation 26.8 (34.1) 27.4 (34.2) -2.2 (35.1) 24.6 0.45 0.19–0.66
QoL 36.6 (26.6) 40.3 (27.5) -3.7 (14.9) 10.8 0.84 0.73–0.91
Abbreviations: OA; osteoarthritis, SD, standard deviation; SEM, standard error of measurement; ICC agreement, intraclass correlation coefficient
for agreement; CI, confidence interval. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each
subscale. Revision of TKA; Revision of total knee arthroplasty, AD; Activities of daily living; QoL; Quality of life.
Table 4: Validity of the KOOS for the patient group with mild OA
KOOS Pain KOOS Symptoms KOOS ADL KOOS Sport/Rec KOOS QOL
SF-36 Subscale
BP 0.60* 0.44 0.63 0.41 0.38
PF 0.64 0.53 0.63* 0.46 0.56
SF 0.23 0.13 0.25 0.09 0.26
RF 0.28 0.37 0.35 0.36 0.40
RE 0.31 0.24 0.19 0.25 0.24
MH 0.42 0.20 0.42 0.30 0.38
VT 0.42 0.27 0.37 0.34 0.31
GH 0.34 0.28 0.35 0.30 0.30
VAS for pain -0.79* -0.71 -0.78 -0.57 -0.59
Validity is expressed by Spearman correlations between KOOS subscales, SF-36 subscales and VAS-pain. Abbreviations: OA; osteoarthritis, BP,
bodily pain; PF, physical function; SF, social function; RF, role limitations because of physical problems; RE, role limitations because of emotional
problems; MH, mental health; VT, vitality; GH, general health perception; ADL, Activities of daily living; QoL, Quality of life. In bold: convergente
correlations that should be 0.60, In Italic: divergente correlations that should be 0.30. All other hypotheses are expected to be between 0.30
and 0.60. Correlations marked by * have to be 0.05 higher than the other convergent correlations.
Health and Quality of Life Outcomes 2008, 6:16 http://www.hqlo.com/content/6/1/16
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In our study, factor analysis was performed on the whole
study population and we found that all items of the Dutch
version of the KOOS questionnaire loaded on one factor.
Our results are in contrast with the conclusion of Roos et
al. that the KOOS items loaded on five factors [6]. How-
ever, our findings are in line with Thumboo et al. and
Faucher et al. who claimed that the subscales Pain and
Physical function of the WOMAC loaded on the same fac-
tor [25-28]. In the present study, the factor loading of the
question S4 (can you straighten your leg fully) was lower
than 0.40 which suggests that this item might be excluded
from the questionnaire. Despite our preliminary results
indicating that the Dutch version of the KOOS question-
naire contains one single factor, we retained in our analy-
ses the original subscales of the Swedish version of the
KOOS questionnaire. However, based on our findings we
recommend additional factor analyses on other data sets,
before changing the number of subscales of the Dutch ver-
sion of the KOOS questionnaire.
In the present study the test-retest reliability was good for
the patient groups with mild OA (ICC 0.74–0.88), mod-
erate OA (ICC 0.87–0.94) and patients after a revision
TKA (ICC 0.73–0.89). A lower ICC (0.45) for patients
after a revision TKA for the subscale Sport/recreation was
found. When deleting all outliers the ICC is still smaller
then 0.70 (ICC 0.62). It is plausible that for these older
patients questions about sport and recreation are less rel-
evant.
The construct validity of the KOOS questionnaire was
determined by comparing the KOOS subscales with the
subscales of the SF-36 and the VAS for pain. Correlations
between subscales, which measure the same construct,
were compared. In our study we found the highest corre-
Table 5: Validity of the KOOS for the patient group with moderate OA
KOOS Pain KOOS Symptoms KOOS ADL KOOS Sport/Rec KOOS QOL
SF-36 Subscale
BP 0.63* 0.57 0.71 0.43 0.62
PF 0.72 0.60 0.75* 0.60 0.70
SF 0.36 0.48 0.50 0.05 0.42
RF 0.23 0.32 0.36 0.12 0.26
RE 0.33 0.39 0.41 0.16 0.46
MH 0.23 0.36 0.27 -0.01 0.25
VT 0.37 0.35 0.48 0.05 0.37
GH 0.32 0.22 0.32 0.13 0.29
VAS for pain -0.69* -0.57 -0.69 -0.38 -0.75
Validity is expressed by Spearman correlations between KOOS subscales, SF-36 subscales and VAS-pain. Abbreviations: OA; osteoarthritis, BP,
bodily pain; PF, physical function; SF, social function; RF, role limitations because of physical problems; RE, role limitations because of emotional
problems; MH, mental health; VT, vitality; GH, general health perception; ADL, Activities of daily living; QoL, Quality of life. In bold: convergente
correlations that should be 0.60, In Italic: divergente correlations that should be 0.30. All other hypotheses are expected to be between 0.30
and 0.60. Correlations marked by * have to be 0.05 higher than the other convergent correlations.
Table 6: Validity of the KOOS for the patient group with severe OA
KOOS Pain KOOS Symptoms KOOS ADL KOOS Sport/Rec KOOS QOL
SF-36 Subscale
BP 0.57* 0.55 0.72 0.37 0.47
PF 0.36 0.27 0.54* 0.12 0.22
SF 0.36 0.42 0.33 0.12 0.49
RF 0.28 0.21 0.37 0.04 0.32
RE 0.13 0.18 0.28 -0.04 0.25
MH 0.11 0.12 0.36 -0.07 0.18
VT 0.26 0.24 0.46 0.10 0.29
GH 0.14 0.03 0.21 -0.11 0.16
VAS for pain -0.28* -0.43 -0.29 -0.19 -0.19
Validity is expressed by Spearman correlations between KOOS subscales, SF-36 subscales and VAS-pain. Abbreviations: OA; osteoarthritis, BP,
bodily pain; PF, physical function; SF, social function; RF, role limitations because of physical problems; RE, role limitations because of emotional
problems; MH, mental health; VT, vitality; GH, general health perception, ADL; Activities of daily living, QoL; Quality of life. In bold: convergente
correlations that should be 0.60, In Italic: divergente correlations that should be 0.30. All other hypotheses are expected to be between 0.30
and 0.60. Correlations marked by * have to be 0.05 higher than the other convergent correlations.
Health and Quality of Life Outcomes 2008, 6:16 http://www.hqlo.com/content/6/1/16
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lations between the KOOS subscales and the SF-36 sub-
scales which are intended to measure the same constructs.
Within the TKA patient group we found some higher cor-
relation coefficients compared to the study of Roos et al.
(ADL vs PF r = 0.83 vs 0.48 and Pain vs PF r = 0.66 vs 0.19)
[8]. The correlations we found within the severe OA
patient group (ranging from r = 0.12 to 0.57) were lower
than found by Xie et al. They found correlations between
r = 0.37 and 0.65 for the English version and r = 0.24 and
0.64 for the Chinese version of the KOOS [24]. Kessler et
al. compared the subscales of the KOOS with the SF-12 for
the same population and found a low correlation between
the subscale Symptoms and the SF-12 (r = 0.05); the other
subscales showed correlations of 0.60 or higher [23].
By only reporting the correlations coefficients it is not
clear whether the construct validity of a questionnaire is
sufficient or not. Therefore Terwee et al. developed quality
criteria for design, methods and outcomes of studies to
compare the measurement properties of health status
questionnaires [22]. These authors recommended assess-
ing the construct validity by testing predefined hypotheses
(e.g., about expected correlations between measures or
expected differences in scores between 'known' groups).
Without specific hypotheses there is a risk of bias, because
retrospectively it is tempting to generate alternative expla-
nations for low correlations instead of concluding that the
questionnaire may not be valid. Terwee et al. give a posi-
tive rating for construct validity if hypotheses are specified
in advance and at least 75% of the results are in corre-
spondence with these hypotheses [22]. Our choice that
convergent correlations should have a correlation coeffi-
cient of 0.60 and divergent correlations of 0.30 is arbi-
trary. However, there is no consensus in literature how to
deal with this issue. From our pre-defined hypotheses
60% or more could be confirmed in both the mild and
moderate OA group and in patients after a TKA (moderate
construct validity). Less than 45% from our hypotheses
Table 7: Validity of the KOOS for the patient group with a primary TKA
KOOS Pain KOOS Symptoms KOOS ADL KOOS Sport/Rec KOOS QOL
SF-36 Subscale
BP 0.62* 0.58 0.72 0.48 0.62
PF 0.66 0.56 0.83* 0.67 0.64
SF 0.39 0.35 0.48 0.26 0.51
RF 0.53 0.53 0.68 0.57 0.49
RE 0.22 0.27 0.39 0.37 0.23
MH 0.46 0.46 0.52 0.37 0.52
VT 0.61 0.48 0.52 0.31 0.49
GH 0.43 0.41 0.49 0.31 0.55
VAS for pain -0.70* -0.58 -0.59 -0.51 -0.27
Validity is expressed by Spearman correlations between KOOS subscales, SF-36 subscales and VAS-pain. Abbreviations: OA; osteoarthritis, BP,
bodily pain; PF, physical function; SF, social function; RF, role limitations because of physical problems; RE, role limitations because of emotional
problems; MH, mental health; VT, vitality; GH, general health perception; ADL, Activities of daily living; QoL, Quality of life. In bold: convergente
correlations that should be 0.60, In Italic: divergente correlations that should be 0.30. All other hypotheses are expected to be between 0.30
and 0.60. Correlations marked by * have to be 0.05 higher than the other convergent correlations.
Table 8: Validity of the KOOS for the patient group with a revision of the TKA
KOOS Pain KOOS Symptoms KOOS ADL KOOS Sport/Rec KOOS QOL
SF-36 Subscale
BP 0.49* 0.39 0.50 0.30 0.54
PF 0.26 0.20 0.44* 0.32 0.36
SF 0.20 0.11 0.24 0.16 0.42
RF 0.12 0.18 0.14 0.24 0.26
RE 0.10 0.09 0.00 -0.01 0.15
MH 0.15 0.26 0.21 0.05 0.28
VT 0.15 0.28 0.18 0.05 0.39
GH 0.09 0.27 0.24 0.22 0.33
VAS for pain -0.47* -0.47 -0.29 -0.30 -0.21
Validity is expressed by Spearman correlations between KOOS subscales, SF-36 subscales and VAS-pain. Abbreviations: OA; osteoarthritis, BP,
bodily pain; PF, physical function; SF, social function; RF, role limitations because of physical problems; RE, role limitations because of emotional
problems; MH, mental health; VT, vitality; GH, general health perception; ADL, Activities of daily living; QoL, Quality of life. In bold: convergente
correlations that should be 0.60, In Italic: divergente correlations that should be 0.30. All other hypotheses are expected to be between 0.30
and 0.60. Correlations marked by * have to be 0.05 higher than the other convergent correlations.
Health and Quality of Life Outcomes 2008, 6:16 http://www.hqlo.com/content/6/1/16
Page 9 of 11
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could be confirmed for patients with severe OA and after
a revision TKA (lower construct validity).
The formulation of the hypotheses was based on the start-
ing point that there is a clear distinction between the sub-
scales of the KOOS questionnaire. However, with factor
analysis we found that all items of the Dutch version of
the KOOS questionnaire seem to load on one factor. This
may explain the overlap between the correlations of the
different constructs of the KOOS questionnaire with the
SF-36. This is most obvious for the subscales Pain and
ADL of the KOOS in relation to the subscales BP and PF
of the SF-36. Previous studies showed that the WOMAC
subscale pain and physical function loaded on the same
factor [25-27]. Apparently it is difficult for patients to
make a distinction between questions about pain and
physical functioning in ADL. In our opinion this can be
ascribed to the formulation of the questions; the term dif-
ficulty (translated in Dutch: 'moeite') may be not clear for
some patients. The meaning of this term should be clari-
fied or re-formulated. This was also suggested by Stratford
et al, and Terwee et al. [29,30].
Because it is known that clinimetric properties are variable
in different study populations [14], it is recommended to
validate a questionnaire in the target population. This
study showed that the clinimetric properties of the Dutch
version of the KOOS questionnaire differed between the 5
different patient groups, which confirms the above
described recommendation. Additionally, in future vali-
dation studies of the KOOS questionnaire, it may be of
interest to evaluate the validity of the Dutch KOOS ques-
tionnaire by comparing the subscales of the KOOS ques-
tionnaire with the Dutch Oxford 12-item knee
questionnaire. This latter questionnaire was considered to
be valid and reliable in patients with OA of the knee [31];
however, it was not validated when we started the present
study.
We observed ceiling effects only in the mild OA patient
group for the subscales Pain, Symptoms and ADL of the
KOOS questionnaire. It is plausible that these patients
have few complaints of their knee and have no or minor
clinical signs of OA, which can explain the presence of
ceiling effects in this group of patients. Floor effects were
only found in the subscale Sport/recreation in the patients
with severe OA and in patients after revision of the TKA.
Roos et al. stated that questions about sport and recrea-
tion also are relevant for older patients [8]. However, this
does not seem to apply for patients after revision of the
TKA. Because of severity of the disease and/or higher age,
it is plausible that these patients do not participate in
sport and recreational activities. Dividing the revision
population into those younger than 65 years and older
than 65 years resulted in floor effects of over 50% in the
older patients. Questions about sport may be more rele-
vant to younger patients than to older patients. Because
the KOOS questionnaire was originally developed for
younger patients this finding is not surprising.
Our study is not without limitations. First, because the
selection of patients in the present study only allows state-
ments on the reliability and validity of the KOOS ques-
tionnaire in patients with different stages of OA and it's
treatment. The questionnaire was not studied in patients
after a menisectomie or an ACL reconstruction. The results
of the present study could not be generalized to patients
with an acute knee trauma.
Second, a measurement tool can also be used to monitor
the efficacy of an intervention or the disease process of the
patient. For this goal the tool needs to be sensitive to
detect clinically relevant changes during a certain period
of time (responsiveness). ICCs are strongly influenced by
the heterogeneity of the study population.
The interpretation of the SEM, i.e. whether it should be
regarded as a large or a small measurement error, depends
on what changes are minimal important on the KOOS
subscales. The smallest detectable change (defined as
1.96*2*SEM) has to be smaller than the minimal impor-
tant changes [20]. Future studies should look at what
changes in scores on the KOOS subscales constitutes min-
imal important change. In addition, the responsiveness of
the KOOS questionnaire needs to be evaluated in a future
study.
Table 9: Percentage ceiling/floor effects of the KOOS (best possible score/worst possible score)
Pain Symptoms ADL Sport/Recreation QoL
Mild OA (n = 36) 28/0 22/0 42/0 14/0 11/0
Moderate OA (n = 62) 13/2 3/0 8/0 10/11 5/2
Severe OA (n = 47) 0/2 0/2 0/0 20/38 0/15
TKA (n = 63) 10/0 3/0 7/0 0/7 6/3
Revision of TKA (n = 54) 2/0 4/0 2/0 6/38 4/4
Abbreviations: OA; osteoarthritis, Revision of TKA, Revision of total knee arthroplasty; ADL, Activities of daily living; QoL, Quality of life.
Health and Quality of Life Outcomes 2008, 6:16 http://www.hqlo.com/content/6/1/16
Page 10 of 11
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Conclusion
Based on these different clinimetric properties within the
present study we conclude that the KOOS questionnaire
seems to be suitable for patients with mild and moderate
OA and for patients with a primary TKA. The Dutch ver-
sion of the KOOS had a lower construct validity for
patients with severe OA on a waiting list for TKA and
patients after revision of a TKA. However, the construct
validity is only assessed by comparing it with the SF-36
and the VAS for pain, not with a knee specific question-
naire. Further validation studies on the Dutch version of
the KOOS should include knee specific questionnaires for
assessing the construct validity.
Competing interests
The author(s) declare that they have no competing inter-
ests.
Authors' contributions
IBG, MMF, CBT and MR designed the study. IBG wrote the
manuscript and guided data collection, analyses and
interpretation. MMF assisted with writing the manuscript,
data collection, analyses and interpretation. CBT critically
reviewed the manuscript and provided input for addi-
tional analyses and for the interpretation. MR and JANV
critically reviewed the manuscript. All authors have read
and approved the final manuscript.
Acknowledgements
The authors thank S.M.A. Bierma-Zeinstra, M. Bierma, L. Blokker and G.
Hagevi for translating and re-translating the Dutch KOOS questionnaire
and, of course, all the patients who participated in this study.
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... 22 Physical functioning: assessed by subscale function in daily living (activities of daily living) of the Dutch translation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire (score 0 = maximal problems; 100 = no problem). 23,24 Secondary outcome measures Global perceived effect: measuring the participant's subjective global change using a 7-point scale ranging from 'worse than ever' to 'completely recovered'. This was dichotomised as follows: recovered Lost to FU before T3 (n = 4) ♦ Withdrawn before T0 (n = 2) ♦ Withdrawn between T0 to T3 (n = 2) Lost to FU after T3 (n = 15) ♦ Withdrawn between T3 to T12 (n = 15) PTs in intervention group (n = 54) + dieticians (n = 21) for 'obesity subgroup' ...
... Lost to FU before T3 (n = 11) ♦ Withdrawn before T0 (n = 5) ♦ Withdrawn between T0 to T3 (n = 6) Lost to FU after T3 (n = 11) ♦ Withdrawn between T3 to T12 (n = 11) Physical functioning: assessed by the short version of the Dutch translation of the KOOS questionnaire (0 = maximal problems; 100 = no problem). 23,24 Pain interference: assessed by the short version of the Patient Reported Outcomes Measurement Information System (PROMIS) (4 = best score; 20 = worst score). 25 Fatigue: assessed by the short version of PROMIS (4 = best score; 20 = worst score). ...
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The influence of sex on preoperative expectations and their fulfillment following total hip and knee arthroplasty (THA/TKA) remains unexplored. We investigated differences between men and women in perceived preoperative expectations on the outcome of THA/TKA and their fulfillment 1 year postoperatively. We performed a cohort study. Expectations were collected preoperatively and 1 year postoperatively using the Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys (HSS-HRES/KRES; not applicable = 0, applicable: back to normal = 1, much = 2/moderate = 3/slight improvement = 4). Fulfillment of expectations was calculated by subtracting preoperative from postoperative scores (score < 0:unfulfilled; score ≥ 0:fulfilled). We included patients with “applicable” expectations. Chi-square and ordinal regression were used to compare expectations and fulfillment regarding sex. 2333 THA (62% women) and 2398 TKA (65% women) patients were included. 77% of THA and 76% of TKA patients completed the HSS-HRES/HSS-KRES both preoperatively and 1 year postoperatively. Men more often perceived items as “applicable”, with differences in 9/20 (HSS-HRES) and 9/19 (HSS-KRES) preoperative items and, respectively, 12/20 (HSS-HRES) and 10/19 (HSS-KRES) postoperative items. The largest differences (> 10%) were found in sexual activity and working ability. 16/20 (HSS-HRES) and 14/19 (HSS-KRES) items showed an increased probability of having higher preoperative expectations of ≥ 10%, in favor of men. In all items, 60% of the respondents indicated that their expectation was fulfilled. Differences were observed in 16/20 (HSS-HRES) and 6/19 (HSS-KRES) items in favor of men. Sex differences were present in expectations and fulfillment, with higher applicability of items, preoperative expectations and fulfillment in men, especially on items related to functional activities. Trial registration: Trial-ID NTR3348.
... Proper technique for pin insertion and meticulous pin tract care, pin site infection may be the most common complication, occurring in 30% of patients. It varies from minor inflammation remedied by local wound care, to superficial infection requiring antibiotics, local wound care, occasional pin removal and osteomyelitis requiring sequestrectomy (10) . ...
... The Dutch version has good validity. 6 ...
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Background The Anterior Cruciate Ligament–Quality of Life (ACL-QoL) questionnaire is a valid and reliable injury-specific instrument to assess the impact of an ACL rupture on the daily life of a patient. Purpose To translate the ACL-QoL into Dutch (ACL-QoL-NL) and to study its psychometric properties in patients with an ACL rupture. Study Design Cohort study (diagnosis); Level of evidence, 2. Methods The original ACL-QoL questionnaire was translated from English to Dutch according to international guidelines. The study population consisted of 122 patients with a confirmed ACL rupture who completed the ACL-QoL-NL as well as 4 questionnaires: the International Knee Documentation Committee subjective score, Knee injury and Osteoarthritis Outcome Score, 36-item Short Form Health Survey, and Lysholm Knee Score. We determined the internal consistency, construct validity, and prevalence of floor and ceiling effects of the ACL-QoL-NL total score as well as its 5 subscales. To determine test-retest reliability, we analyzed the data of 68 patients who had a stable knee condition and who completed the ACL-QoL-NL a second time after a 2-week interval. Results The confirmatory factor analysis showed that the original structure of the ACL-QoL-NL was confirmed, except for 4 of 31 items. Internal consistency of the total scale and all 5 subscales was good. More than 75% of the predefined hypotheses on the correlations between the ACL-QoL-NL and the 4 questionnaires were met, indicating good construct validity. No significant floor or ceiling effects were observed. Test-retest reliability was good, and no systematic bias between test and retest was found. Standard error of measurement for the total score was 4.8 points out of 100, and the smallest detectable changes at the group and individual levels were 1.6 and 13.2 points, respectively. Conclusion The ACL-QoL-NL questionnaire was successfully translated from English to Dutch and demonstrated good internal consistency, validity, and reliability, with no presence of floor or ceiling effects.
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Background Total hip or knee arthroplasties (THA/TKA) show favorable long-term effects, yet the recovery process may take weeks to months. Physical therapy (PT) following discharge from hospital is an effective intervention to enhance this recovery process. To investigate the relation between recovery and postoperative PT usage, including the presence of comorbidities, 6 months after THA/TKA. Methods Multicenter, observational study in primary THA/TKA patients who completed preoperative and 6 months postoperative assessments. The assessments included questions on PT use (yes/no and duration; long term use defined as ≥ 12 weeks), comorbidities (musculoskeletal, non-musculoskeletal, sensory comorbidities and frequency of comorbidities). Recovery was assessed with the HOOS/KOOS on all 5 subdomains. Logistic regression with long term PT as outcome was performed adjusted for confounding including an interaction term (comorbidity*HOOS/KOOS-subdomain). Results In total, 1289 THA and 1333 TKA patients were included, of whom 95% received postoperative PT, 56% and 67% received postoperative PT ≥ 12 weeks respectively. In both THA and TKA group, less improvement on all HOOS/KOOS domain scores was associated with ≥ 12 weeks of postoperative PT (range Odds Ratios 0.97–0.99). In the THA group the impact of recovery was smaller in patient with comorbidities as non- musculoskeletal comorbidities modified all associations between recovery and postoperative PT duration (Odds Ratios range 1.01–1.05). Musculoskeletal comorbidities modified the associations between Function-in-Daily-Living-and Sport-and-recreation recovery and postoperative PT. Sensory comorbidities only had an effect on Sport-and-recreation recovery and postoperative PT. Also the frequency of comorbidities modified the relation between Function-in-Daily-Living, pain and symptoms recovery and postoperative PT. In the TKA group comorbidity did not modify the associations. Conclusion Worse recovery was associated with longer duration of postoperative PT suggesting that PT provision is in line with patients’ needs. The impact of physical recovery on the use of long-term postoperative PT was smaller in THA patients with comorbidities. Trial registration Registered in the Dutch Trial Registry on March 13, 2012. TRIAL ID NTR3348; registration number: P12.047. https://www.trialregister.nl/trial/3197 .
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Introduction The incidence of degenerative disorders, including osteoarthritis (OA), increases rapidly in women after menopause. However, the influence of the menopause is still insufficiently investigated due to the slowness of menopausal transition. In this study, a novel human model is used in which it is expected that menopausal-related changes will occur faster. This is the Females discontinuing Oral Contraceptives Use at Menopausal age model. The ultimate aim is to link these changes to OA and other degenerative disorders, including cardiovascular diseases, diabetes, osteoporosis and tendinopathies. Methods and analysis This is a pilot observational prospective cohort study with 2 years of follow-up. Fifty women aged 50–60 who use oral contraceptive (OC) and have the intention to stop are included. Measurements are performed once before stopping OC, and four times thereafter at 6 weeks, 6 months, 1 year and 2 years. At every time point, a questionnaire is filled in and a sample of blood is drawn. At the first and final time points, a physical examination, hand radiographs and a MRI scan of one knee are performed. The primary OA outcome is progression of the MRI Osteoarthritis Knee Score. Secondary OA outcomes are the development of clinical knee and hand OA, development of knee OA according to the MRI definition, and progression of radiographic features for hand OA. Principal component analysis will be used to assess which changes occur after stopping OC. Univariate and multivariate generalised estimating equation models will be used to test for associations between these components and OA. Ethics and dissemination The study has been approved by the Medical Ethics Committee of the Erasmus MC University Medical Center Rotterdam (MEC-2019-0592). All participants must give informed consent before data collection. Results will be disseminated in national and international journals. Trial registration number NL70796.078.19.
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Background and aim The Work Osteoarthritis or joint-Replacement Questionnaire (WORQ) is a new assessment tool developed in the Netherlands. It needs translation and cross-cultural adaptation for use in each country. The aim of this study was to translate the Work Osteoarthritis or joint-Replacement Questionnaire into Korean and to verify its reliability and validity. Methods To evaluate the clinimetric quality of the Korean-WORQ, we performed tests for internal consistency (Cronbach's alpha), reliability (intra-class correlation coefficients) and concurrent validity (Spearman's correlation coefficient). Factor analysis was carried out to identify the principal components of the questionnaire. Findings Both the internal consistency and intra-class correlation coefficients showed the reliability of the Korean-WORQ to be excellent. The Korean-WORQ had a strong positive correlation with the Western Ontario and McMaster Universities Osteoarthritis Index and three components were extracted in factor analysis. Conclusions Based on these results, the Korean-WORQ seems to be a suitable questionnaire for assessing the disability levels of patients with knee injuries.
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Background Inertial sensors hold the promise to objectively measure functional recovery after total knee (TKA) and hip arthroplasty (THA), but their value in addition to patient-reported outcome measures (PROMs) has yet to be demonstrated. This study investigated recovery of gait after TKA and THA using inertial sensors, and compared results to recovery of self-reported scores of pain and function. Methods PROMs and gait parameters were assessed before and at two and fifteen months after TKA ( n = 24) and THA ( n = 24). Gait parameters were compared with healthy individuals ( n = 27) of similar age. Gait data were collected using inertial sensors on the feet, lower back, and trunk. Participants walked for two minutes back and forth over a 6m walkway with 180° turns. PROMs were obtained using the Knee Injury and Osteoarthritis Outcome Scores and Hip Disability and Osteoarthritis Outcome Score. Results Gait parameters recovered to the level of healthy controls after both TKA and THA. Early improvements were found in gait-related trunk kinematics, while spatiotemporal gait parameters mainly improved between two and fifteen months after TKA and THA. Compared to the large and early improvements found in of PROMs, these gait parameters showed a different trajectory, with a marked discordance between the outcome of both methods at two months post-operatively. Conclusion Sensor-derived gait parameters were responsive to TKA and THA, showing different recovery trajectories for spatiotemporal gait parameters and gait-related trunk kinematics. Fifteen months after TKA and THA, there were no remaining gait differences with respect to healthy controls. Given the discordance in recovery trajectories between gait parameters and PROMs, sensor-derived gait parameters seem to carry relevant information for evaluation of physical function that is not captured by self-reported scores.
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Within the context of a double blind randomized controlled parallel trial of 2 nonsteroidal antiinflammatory drugs, we validated WOMAC, a new multidimensional, self-administered health status instrument for patients with osteoarthritis of the hip or knee. The pain, stiffness and physical function subscales fulfil conventional criteria for face, content and construct validity, reliability, responsiveness and relative efficiency. WOMAC is a disease-specific purpose built high performance instrument for evaluative research in osteoarthritis clinical trials.
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