KOOS FAQ
What is the KOOS?
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported outcome
measurement instrument, developed to assess the patient's opinion about their knee and
associated problems. The KOOS evaluates both short-term and long-term consequences of knee
injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five
separately scored subscales: KOOS Pain, KOOS Symptoms,
Function in daily living (KOOS ADL),
Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality
of Life (KOOS
QOL) (Roos and Lohmander 2003).
Why assess health-related Quality of Life with the KOOS?
The main reason for developing a single instrument with the purpose of covering several types
of knee injury and including osteoarthritis (OA) was that traumatic knee injuries often
cause concomitant damage to multiple structures (ligaments, menisci, cartilage, etc.) and
frequently lead to the subsequent development of OA. To be able to follow patients after a
trauma and to gain insight into the change in symptoms, function, etc. over time, a
questionnaire, which covers both the short-term and long-term consequences is needed. Prior
instruments such as the Lysholm knee scoring scale have focused only on the short-term
consequences, and instruments such as the WOMAC Osteoarthritis Index only on the long-term
consequences. An instrument intended for use in follow-up evaluation of these patients needs
to adequately monitor both the acute injury consequences in the physically active and
younger patients, as well as the chronic outcomes in the elderly (Roos and Lohmander
2003).
What are the applications of the KOOS?
The KOOS is intended to be used over short and long time intervals; to assess changes from
week to week induced by treatment (medication, surgery, physical therapy) or over the years
due to a primary knee injury, posttraumatic OA or primary OA (Roos
and Lohmander 2003).
In which populations can the KOOS be used?
KOOS has been used in patients 13-79 years of age.
KOOS is intended to be used for knee injury that can result in posttraumatic osteoarthritis
(OA); i.e. knee ligament injury (ACL, posterior cruciate ligament [PCL], medial collateral
ligament [MCL]), meniscal tears, knee cartilage lesions, knee OA, and osteochondritis
dissecans, etc.
KOOS is meant to be used over short and long time intervals; to assess changes from week to
week induced by treatment (examples include: ligament reconstruction (ACL, PCL, MCL),
meniscectomy, microfracture, osteochondral autografts, tibial osteotomy, total knee
replacement (TKR), exercise (land-based, aquatic-based), intra-articular sodium hyaluronate
injection, pharmacologic therapy, and glucosamine supplementation) or over years due to the
primary injury, post traumatic OA or primary OA (Roos and
Lohmander 2003).
How was the KOOS developed?
KOOS was developed by Ewa Roos and co-authors in the 1990s as an instrument to assess the
patient's opinion about their knee and associated problems. Items were selected based on:
(1) the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), version 3.0;
(2) a literature review; (3) an expert panel (patients referred to physical therapy for knee
injuries, orthopedic surgeons, and physical therapists from Sweden and the US); and, (4) a
pilot study of two questionnaires (one for symptoms of ACL injury, one for symptoms of OA)
in individuals with posttraumatic OA.
What are the KOOS subscales and what areas of health do they measure?
The KOOS collects data on five knee-specific patient-centered outcomes: (1) KOOS
Pain; (2)
KOOS Symptoms: Other symptoms such as swelling, restricted range of motion
and mechanical
symptoms; (3) KOOS ADL: Disability on the level of daily activities; (4)
KOOS Sport/Rec:
Disability on a level physically more demanding than activities of daily living; (5)
KOOS
QOL: Quality of life, mental and social aspects such as awareness and lifestyle
changes.
KOOS translations
What translations are available?
The English and Swedish versions were developed concurrently. For a full list of available
language versions please visit:
https://eprovide.mapi-trust.org/instruments/knee-injury-and-osteoarthritis-outcome-score
Do you want to translate the KOOS into another language?
If you want to translate the KOOS into a new language, please visit
https://eprovide.mapi-trust.org/instruments/knee-injury-and-osteoarthritis-outcome-score
and
submit a request. We recommend that you follow the guidelines for cross-cultural validation
proposed by Beaton et al. (Beaton, Bombardier
et
al. 2000).
As soon as the linguistic process (and if applicable, the clinical validation study) is
ready, we offer to publish the new language version on our website, www.koos.nu. We will
assist in the appropriate formatting of the questionnaire. An abstract describing the
linguistic process (and if available, the results from a clinical validation study) should
accompany the questionnaire. The reason we offer to publish the new language version after
the linguistic process is completed, is to minimize the risk of multiple versions being
created by different translators simultaneously. This policy also enables other authors to
perform clinical validation studies of the already linguistically-validated version. The
stage of validation (linguistic and/or psychometric) is always evident from the abstract
accompanying all the different language versions available at www.koos.nu.
In what settings have the measurement properties of the KOOS been
evaluated?
In what settings have test-retest reliability of the KOOS been evaluated?
Test-retest reliability is critical because the measurement precision of an attribute is
inversely related to the size of the measurement error (Roos, Engelhart et al. 2011).
In studies of patients with knee injury, intraclass correlation coefficients (ICCs) for KOOS
Pain range from 0.85-0.95, KOOS Symptoms from 0.75-0.91, KOOS ADL from 0.75-0.91, KOOS
Sport/Rec
from 0.61-0.89 and KOOS QOL from 0.83-0.95. The minimal detectable changes were for KOOS
Pain
6-6.1, for KOOS Symptoms 5-8.5, for KOOS ADL 7-8, for KOOS Sport/Rec 5.8-12, and for KOOS
QOL
7-7.2 (Collins, Misra et al. 2011).
In studies of patients with knee OA, ICCs for KOOS Pain range from 0.8-0.97, KOOS Symptoms
from
0.74-0.94, KOOS ADL from 0.84-0.94, KOOS Sport/Rec from 0.65-0.92 and KOOS QOL from 0.6-0.91
(Collins, Misra et al. 2011).
In what settings have KOOS' internal consistency (Cronbach's α) been evaluated?
In studies of patients with knee injuries, the internal consistency range (Cronbach's α) for
KOOS Pain was 0.84–0.91, for KOOS Symptoms: 0.25–0.75, for KOOS ADL: 0.94–0.96, for KOOS
Sport/Rec: 0.85–0.89, and for KOOS QOL: 0.64–0.9 (Collins, Misra et
al. 2011).
In studies of patients with knee OA the internal consistency range for KOOS Pain was
0.65–0.94,
for KOOS Symptoms: 0.56–0.83, for KOOS ADL: 0.78–0.97, for KOOS Sport/Rec: 0.84–0.98 and for
KOOS QOL: 0.71–0.85 (Collins, Misra et al. 2011).
How was face and content validity of the KOOS assured?
Content validity of the KOOS has been confirmed in patients with a complete rupture of the
ACL
requiring surgical reconstruction, patients with an isolated meniscal tear of the knee
requiring
arthroscopy, and patients with mild to moderate OA (Kellgren and Lawrence grades I-III) of
the
knee who were treated both non-operatively and operatively by Tanner et al. (Tanner, Dainty
et
al. 2007). They conclude that: "Of general knee instruments studied, the
International
Knee
Documentation Committee Standard Evaluation Form and the Knee injury and Osteoarthritis
Outcome
Score contain the most items important to patients."
The KOOS was developed in 1994-95. At that time, it was not common to report the
developmental
stage in the same detail as it is today (2012). What has been reported about the content
validity is the following (Roos, Roos et al. 1998): "To
ensure content validity for subjects
with ACL injury, meniscus injury, and early osteoarthritis, we reviewed the literature,
consulted an expert panel and conducted a pilot study."… "An expert panel comprised of
patients
referred to physical therapy because of knee injuries, orthopedic surgeons, and physical
therapists from both Sweden and the United States was asked to identify short-term and
long-term
symptoms and functional disabilities resulting from a meniscus or ACL injury."… "A pilot
study
was conducted to identify the subjectively most relevant factors among patients with
posttraumatic osteoarthritis. 75 individuals who had meniscus surgery 20 years
previously
were
asked to respond to two questionnaires, both self-administered. The participants ranged
in
age
from 35 to 76 (mean 56) and showed radiological signs of knee osteoarthritis, defined as
joint
space narrowing and osteophytes. One of the questionnaires was constructed to assess
symptoms of
ACL injury (Flandry, Hunt et al. 1991) and the other for
assessment of OA (Lequesne, Mery et
al.
1987). Questions that most frequently received high responses and were thus
considered to
reflect the most predominant symptoms included those relating to pain, swelling,
stiffness,
and
the ability to run, jump, kneel, and squat."
Additional information (unpublished): Semi-structured interviews were conducted individually
with 30+ patients with knee injury or OA during the developmental phase. The interview guide
included questions such as: What are the most important symptoms you experience from your
knee
injury (OA)? What are the effects of your knee injury (OA) on your function and quality of
life?
Additionally, patients were shown already existing questionnaires (Flandry, Lequesne, WOMAC)
and
were asked to comment on the relevance and importance of the items. These patients were, as
reported, treated with physical therapy or surgery in Sweden or the US, and had different
types
of knee injuries (including ACL, meniscus, and cartilage) or OA.
Additionally, two focus groups (4-5 patients in each group) were held with patients on a
waiting
list for TKR to confirm content validity for this group. When tested in a sample of 105
patients
having TKR (Roos and Toksvig-Larsen 2003), "...over
90% reported that improvement in the four
subscales of Pain, Symptoms, ADL, and QOL was extremely or very important when deciding
to
have
their knee operated on. Also, 51% reported that improvement in functions included in the
subscale Sport and Recreation function such as squatting, kneeling, jumping,
turning/twisting
and running was extremely or very important when deciding to have their knee operated
on.
The
group who reported that items related to Sport and Recreation function were extremely or
very
important had a greater proportion of men but was not biased with regard to age and
preoperative
ADL function" (Roos and Toksvig-Larsen 2003).
In what settings have KOOS' construct validity been evaluated?
Multiple studies in patients with knee injury and knee OA report that the KOOS demonstrates
expected convergent and divergent construct validity, with the KOOS more strongly correlated
with subscales of the ShortForm- 36 (SF-36) that measure similar constructs (e.g., KOOS ADL
with
physical function, KOOS Sport/Rec with physical function, KOOS Pain with bodily pain), and
less
strongly with SF-36 subscales that measure mental health (Collins,
Misra et al. 2011). Rasch
analysis conducted using patient data 20 weeks post–ACL reconstruction showed that only the
KOOS
Sport/Rec and KOOS QOL subscales exhibited unidimensionality, not the three subscales that
were
based on the WOMAC. A more recent study reported that the KOOS subscales had acceptable
dimensionality in this patient group (Salavati, Akhbari et al.
2011).
In what settings is the KOOS responsive to change?
KOOS' responsiveness has been reported following surgical procedures including ACL
reconstruction, meniscectomy, cartilage repair procedures, tibial osteotomy, total knee
replacement as well as physical therapy, nutritional and pharmaceutical interventions.
Following
orthopedic surgery, including total knee replacement, KOOS QOL is usually as responsive, or
more
responsive, than KOOS Pain and KOOS ADL (Collins and Roos 2012).
What is the Minimal Detectable Change of the KOOS in different settings?
The minimal detectable change (MDC) is dependent on the test-retest reliability of an
instrument. The more reliable a measure is, the smaller the difference that can be detected
longitudinally. The test-retest reliability is, in turn, dependent on factors such as
patient
characteristics and time between assessments.
In studies of patients with knee injury, the MDC ranges for KOOS Pain were 6-6.1, for KOOS
Symptoms: 5-8.5, for KOOS ADL: 7-8, for KOOS Sport/Rec: 5.8-12, and for KOOS QOL: 7-7.2
(Collins, Misra et al. 2011).
In one study including patients with knee OA, the MDCs for KOOS Pain were 13.4, for KOOS
Symptoms: 15.5, for KOOS ADL: 15.4, for KOOS Sport/Rec: 19.6, and for KOOS QOL: 21.1
(Collins,
Misra et al. 2011).
What is the Minimal clinically Important Change in the KOOS in different settings
The minimal clinically important change (MIC) can be defined as the smallest
change score
needed
for the effect to be considered clinically relevant (de Vet, Ostelo et al. 2007). MIC can be
calculated in many different ways using anchor-based and distribution-based methods. Recent
publications highlight that there is probably no such thing as one MIC for a specific
patient-reported outcome measure, such as the KOOS. Instead MIC seems to be dependent on
context
factors including patient group, intervention, time to follow-up, etc. Therefore, it is more
probable that in the future, a range of MICs will be established for an instrument. Research
is
ongoing to establish the MIC for the KOOS in many different contexts. Until then, a MIC of
8-10
is considered appropriate for the KOOS (Roos and Lohmander
2003). For performing a sample
size
calculation, usually an SD of 15 can be used. However, the variation within the group
to be
studied will depend on the characteristics of the group. Usually elderly or more impaired
groups
have greater within-group variation than younger or healthier groups.
What is the Patient Acceptable Symptom State of the KOOS in different settings?
The Patient Acceptable Symptom State (PASS) can be defined as the value beyond which the
patients can consider them well. The PASS is an absolute value (not a change value) and can
be used as a patient centered and clinically relevant treatment target (the proportion of
patients reaching a satisfactory state) (Tubach, Ravaud et al.
2005). Similar to the MIC,
research is ongoing within this area to establish PASS for KOOS when used in different
contexts. A systematic review from 2022 summarizes meaningful thresholds for
patient-reported outcomes (including KOOS) for young patients with ACL or meniscus injury
(Macri et al. 2022)
Where can I find normative data/reference values?
KOOS reference values are available from several groups including population-based samples
from different countries (references include but are not limited to: Paradowski, Bergman et al. 2006, Williamson et al. 2016,
Larsen et al. 2023), a group of active soccer players
(Frobell, Svensson et
al.
2008), a group of healthy female soccer players (Östenberg,
Roos et al. 2000), male and female patients following ACL reconstruction (Ageberg, Forssblad et al.
2010), and from another population-based group of 50 participants (mean 53 years,
37-79)
who had no previous and no current clinical signs of injury to the ACL or menisci and no
radiographic signs of OA (Roos, Roos et al. 1999).
KOOS administration
Who answers the questionnaire?
The KOOS is self-administered and completed by the patient. No interview or phone formats are
available.
How long does it take to complete the KOOS?
The KOOS questionnaire takes about 10 minutes to fill out.
How is the KOOS administered?
The KOOS is self-explanatory and can be administered in the waiting room prior to a clinical
visit or used in an electronic or paper-based survey. A study found an electronic version of
KOOS to be comparable to the paper version (Gudbergsen, Bartels et
al. 2011). KOOS has not
been validated for interview administration (Collins, Misra et al.
2011).
Do we need permission to use it?
Permission is required to use the KOOS. Please contact MAPI Trust:
https://eprovide.mapi-trust.org/instruments/knee-injury-and-osteoarthritis-outcome-score
Are there any costs associated with using the KOOS?
The instruments are free to use for non-funded and funded academic users. A permission is
however always required. Corresponding fees will be required, which is dependent on the type
of user ranging from non-for-profit healthcare organizations, for-profit healthcare
organizations and commercial users.
Is there an electronic format available?
KOOS is available in paper format only from koos.nu. Excel scoring files are also available
from koos.nu. There are however a range of electronic (commercial and non-commercial)
software applications where the KOOS is included. You may however not change the format or
the text compared to the paper-based version. A recent study found an electronic version of
KOOS to be comparable to the paper version (Gudbergsen, Bartels et al. 2011). If you are
interested in developing an electronic version of the KOOS then please submit a request via
the following link:
https://eprovide.mapi-trust.org/instruments/knee-injury-and-osteoarthritis-outcome-score
KOOS Scores
How is the KOOS scored?
The five patient-relevant subscales of KOOS are scored separately: KOOS Pain (9 items); KOOS
Symptoms (7 items); KOOS ADL (17 items); KOOS Sport/Rec (5 items); KOOS QOL (4 items). A
Likert
scale is used and all items have five possible answer options scored from 0 (No Problems) to
4
(Extreme Problems) and each of the five scores is calculated as the sum of the items
included.
Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and
100
representing no knee problems as is common in orthopaedic assessment scales and generic
measures. Scores between 0 and 100 represent the percentage of total possible score
achieved. An
aggregate total score is not calculated since it is regarded desirable to analyze and
interpret
the five dimensions separately. Please find more extensive instructions on score
calculations in
the scoring section of the KOOS User's Guide.
For statistical purposes, when used as the primary outcome in an RCT, a single score can be
constructed. In this case, the five individual subscale scores should be secondary outcomes.
Please see reference (Roos, Engelhart et al. 2011) for more
information on this
procedure.
How are the KOOS scores interpreted?
The score is a percentage score from 0 to 100, with 0 representing extreme problems and 100
representing no problems. This scoring direction, 100 indicating no problems, is common in
orthopaedic instruments and generic measures like the SF-36. In measures developed by
rheumatologists, like the WOMAC, 100 usually represents the worst possible result.
How should the patient be instructed on scoring activities he/she is not able to
perform?
It is important to determine whether or not each subscale is relevant at the time point
chosen,
considering the specific study population. For example, difficulty with Sport/Rec function
may
not be relevant to assess 2 weeks post-operatively.
The following guideline for study staff is available:
KOOS Pain and KOOS ADL subscales: If a subject avoids an activity (e.g., twisting/pivoting
or
going up or down stairs) due to doctor's orders or because the subject has chosen to avoid
the
activity, the subject should be instructed to choose "(4) Extreme" for those items.
KOOS Sport/Rec subscale: The same as above. Also, if a subject does not normally engage in
an
activity (e.g., running or jumping), the subject should be instructed to leave the item
blank.
How do I handle missing items?
Missing data: If a mark is placed outside a box, the closest box is chosen. If two boxes are
marked, that which indicates the more severe problem is chosen.
As long as at least 50% of the subscale items are answered for each subscale, a mean score
can
be calculated. If more than 50% of the subscale items are omitted, the response is
considered
invalid and no subscale score should be calculated. For KOOS Pain, this means that 5 items
must
be answered; for KOOS Symptoms, 4 items; for KOOS ADL, 9 items; for KOOS Sport/Rec, 3 items;
and
for KOOS QOL, 2 items in order to calculate a subscale score. Subscale scores are
independent
and can be reported for any number of the individual subscales, i.e. if a particular
subscale is
not considered valid (for example, KOOS Sport/Rec 2 weeks after total knee replacement), the
results from the other subscales can be reported at this time-point.
Can a total score be calculated?
An aggregate total score is not calculated since it is regarded desirable to analyze and
interpret the five dimensions separately. For statistical purposes, when used as the primary
outcome in an RCT, a single score can be constructed. In this case, the five individual
subscale
scores should be secondary outcomes. For more information on this procedure, see reference
(Roos, Engelhart et al. 2011) or the FAQs section on statistics.
How do I present my data?
The results of the five subscales can be plotted as an outcome profile, preferably in a
graph
with scores from 0-100 on the y-axis and the five subscales on the x-axis (an example is
presented in the KOOS User's Guide,
under the heading of KOOS Profile). The order of the
subscales from left to right should be: KOOS Pain, KOOS Symptoms, KOOS ADL, KOOS Sport/Rec
and
KOOS QOL. This way profiles can be compared visually across studies. Changing this order
makes
visual comparison more difficult.
How do I use KOOS as the primary outcome in an RCT?
There are two ways to apply the KOOS as the primary outcome in an RCT. Either way, the
primary
endpoint should be specified a priori. You can either (1) choose the single subscale you
consider is the most likely to measure the change from the intervention of interest, or you
can
(2) create a composite score, referred to as KOOS4 or KOOS5, depending on the number of
subscales included in this composite score. Please note that this is very different from
calculating a total score! Calculating an average score from subscale scores ensures
similar
weight from all subscales in the composite score. Calculating a total score is never
recommended. In either case, all KOOS subscales should be included as secondary endpoints to
enable clinical interpretation of the results.
As examples, since exercise is aimed at improving physical function, it may be appropriate
to
apply the KOOS ADL subscale as the primary endpoint in an older group of OA patients, and
the
KOOS Sport/Rec subscale as the primary endpoint in a younger group of knee-injured patients
in a
trial of an exercise intervention. However, in pharmacological trials, the subscale KOOS
Pain
may be more appropriate as the primary endpoint since pharmacological agents often are
supposed
to relieve pain. When two different interventions are included (for example a surgical and a
non-surgical) or when the intervention is supposed to affect more than one subscale to a
similar
degree, a composite score may be most appropriate as the primary outcome. Below, an example
is
given where KOOS4 was applied. You can also read more about "Single Subscale versus Overall
score" and "Multiplicity" in the review by Roos et al (Roos,
Engelhart et al. 2011).
What is KOOS4?
KOOS4 is an example of how the KOOS was used as the primary endpoint in an RCT on treatment
of
acute ACL injury. KOOS4 was first used in the paper by Frobell et al, published in the New
England Journal of Medicine in 2010 (Frobell, Roos et al. 2010).
In this paper, studying the
effects of surgical reconstruction and exercise as treatments of acute ACL injury, a single
outcome was preferred for the RCT. After a discussion within the author group, based on
knowledge about previously published KOOS results, it was decided to construct an average
score
for four out of the five KOOS subscale scores. The reason for not including all five
subscale
scores was that in this group of patients, difficulties with ADL function is at most mild if
existing at all. Including the subscale ADL would then add unwanted ‘noise' to the
constructed
outcome.
KOOS4 was calculated as the average score of the four subscale scores for KOOS Pain, KOOS
Symptoms, KOOS Sport/Rec and KOOS QOL. Please note that this is very different from
calculating
a total score! Calculating an average score from subscale scores ensures similar
weight from
all
subscales in the primary outcome (KOOS4).Calculating a total score is never recommended.
Doing
so would significantly increase the influence of ADL function on the total score since the
subscale KOOS ADL holds 17 items to be compared with KOOS Pain (9 items), KOOS Symptoms (7
items), KOOS Sport/Rec (5 items) and KOOS QOL (4 items).
How do I estimate the sample size needed in my study?
When using the KOOS, a change of 8-10 is most commonly considered the minimally important
change
(MIC) and the standard variation is set to 15. These numbers are recommendations but may of
course vary depending on your setting. You are always responsible for performing your own
sample
size estimation and make sure that the data you enter into the calculation is appropriate
for
your study design and patient group. Please refer to the MIC section of this FAQs for more
complete information .
How is the KOOS used in individual patients?
KOOS is also widely used for clinical purposes. In the clinic, KOOS is used to monitor
groups
and individuals over time. When completed prior to a consultation, due to its
comprehensiveness,
KOOS can be used to guide the consultation as to the symptoms and difficulties experienced
by
the patient.
Do you have any other questions regarding KOOS?
For information on, or permission to use the KOOS©, please contact Mapi Research Trust
at: https://eprovide.mapi-trust.org/instruments/knee-injury-and-osteoarthritis-outcome-score
References
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