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Patient-Reported Outcomes inTotal Knee Arthroplasty
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125
12
. Table 12.1 Short-Form subscales and 36- and 12-items
Summary measures Scale Items
Physical component
summary (PCS)
Mental component
summary (MCS)
a
SF-12 items are highlighted in bold
Physical
functioning (PF)
Role– Physical
(RP)
Bodily pain (BP) Pain magnitude
General health
(GH)
Vitality (VT) Pep/life
Social functioning (SF)
Role– Emotional (RE)
Mental health
(MH)
a
Vigorous
activities
Moderate
activities
Lift, carry
groceries
Climb several
ights
Climb one ight
Bend, kneel
Walk mile
Walk several
blocks
Walk one block
Bathe, dress
Cut downtime
Accomplished
less
Limited in kind
of work
Had difculty
Paininterfere
General health
rating
Sick easier
As healthy
Health to get
worse
Health excellent
Energy
Worn out
Tired
Social extent
Social time
Cut downtime
Accomplished
less
Not careful
Nervous
Down in dumps
Peaceful
Blue/sad
Happy
Clement etal. studied the minimally clinically important
difference (MCID) for the SF-12 scores in TKA (Clement etal. 2019). They identied 2589 TKAs performed
in a 10-year period, and collected SF-12 scores preoperatively and at one-year postoperatively. They found
that the MCID for the physical component (PCS) to be
1.8, and for the mental component (MCS) to be 1.5.
This indicated that in order to power a randomized controlled trial with 80% power and an alpha of 0.05, 394
patients would need to be randomized to each arm.
12.2.2 EuroQOL 5-Dimension Score (EQ-5D)
The EuroQol 5-dimension (EQ-5D) is one of the most
commonly used generic measures of health status developed by the EuroQol Group (EuroQol Group 1990;
Brooks 1996). Applicable to a wide range of health conditions and treatments, the EQ-5D is designed for selfcompletion by respondents and is ideally suited for use
in postal surveys, in clinics, and in face-to-face interviews. It takes only a few minutes to complete. This survey consists of two pages: the EQ-5D descriptive system
and the EQ visual analogue scale (EQ VAS) (EQ-5D
instruments– EQ-5D 2021).
The descriptive system includes ve health outcome
domains or dimensions, which are the following:
5 Mobility.
5 Self-care.
5 Usual activities.
5 Pain/discomfort.
5 Anxiety/depression.
In the original EQ-5D 3-level version (EQ-5D-3L), each
dimension had three levels: No problems, some problems, extreme problems.
In 2005, a task force was established within the
EuroQol Group to improve the instrument’s sensitivity
and reduce the ceiling effect. The group decided that the
new version of the EQ-5D should include ve levels of
severity in each of the existing ve domains, and was
renamed EQ-5D-5L (.
Fig.12.1) (Herdman etal. 2011).
Each dimension has ve levels of perceived problems:
5 No problems.
5 Slight problems.
5 Moderate problems.
5 Severe problems.
5 Extreme problems.
The descriptive system denes health in a total of 3125
health states; each state is referred to in terms of a vedigit code. For example, state 11,111 indicates no problem in any of the ve dimensions. These states are then
converted into a single index value using a crosswalk
link function (van Reenen and Janssen 2019).
The EQ VAS records the patient’s self-rated health
on a vertical visual analogue scale, where the endpoints
are labeled “the best health you can imagine” and “the
worst health you can imagine” (.
Fig.12.1b).
126
Under each heading, please tick the ONE box that best describes your health TODAY.
MOBILITY
I have no problems in walking about
I have slight problems in walking about
I have moderate problems in walking about
I have severe problems in walking about
I am unable to walk about
SELF-CARE
I have no problems washing or dressing myself
I have slight problems washing or dressing myself
I have moderate problems washing or dressing myself
I have severe problems washing or dressing myself
I am unable to wash or dress myself
USUAL ACTIVITIES
I have no problems doing my usual activities
I have slight problems doing my usual activities
I have moderate problems doing my usual activities
I have severe problems doing my usual activities
I am unable to do my usual activities
PAIN / DISCOMFOR
I have no pain or discomfor
I have slight pain or discomfor
I have moderate pain or discomfor
I have severe pain or discomfor
I have extreme pain or discomfor
ANXIETY / DEPRESSION
I am not anxious or depresse
I am slightly anxious or depresse
I am moderately anxious or depresse
I am severely anxious or depresse
I am extremely anxious or depresse
a
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A. Saleh and D. Nam
Shim etal. studied the responsiveness of the EQ-5D
questionnaire in patients undergoing TKA (Shim and
Hamilton 2019). They used data from a prospective
multicenter cohort study in the United Kingdom,
including 721 patients. With regards to internal respon-
12
. Fig. 12.1 UK sample version of EuroQOL 5-Dimension Score
(EQ- 5D- 5L Health Questionnaire). a The rst page is descriptive, b
the second page is showing a visual analogue scale. (© EuroQol
Research Foundation. EQ-5D™ is a trademark of the EuroQol
Research Foundation. Reproduced by permission of EuroQol
(e.g. work, study, housework, family or leisure activities)
T
t
t
t
t
t
d
d
d
d
d
siveness, the EQ-5D showed signicant change between
preoperative and postoperative scores, with most
improvement occurring during the rst 3 months in all
patients. There was a small but signicant change
between 3 and 6 months, and no further statistical
Research Foundation. Reproduction of this version is not allowed.
For reproduction, use, or modication of the EQ-5D [any version],
please register your study by using the online EQ registration page:
7 www. euroqol. org)
you can imagine
•
•
•
•
•
The best health
100
b
Patient-Reported Outcomes inTotal Knee Arthroplasty
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We would like to know how good or bad your health is TODAY.
you can imagine
127
12
This scale is numbered from 0 to 100.
100 means the best health you can imagine.
0 means the worst health you can imagine.
Please mark an X on the scale to indicate how your health is TODAY.
Now, write the number you marked on the scale in the box below.
YOUR HEALTH TODAY =
95
90
85
80
75
70
65
60
55
50
45
40
35
30
25
20
15
. Fig. 12.1 (continued)
change between 6 and 12months. External responsiveness was assessed by correlating change scores of the
EQ-5D with the MCID of the Oxford Knee Score
(OKS). Their study showed that the EQ-5D was able to
discriminate between patients who achieved the OKS
score MCID (>5) and those who did not.
> Both SF-12 and EQ-5D-5L tools are commonly used
in total joint arthroplasty studies, and there are no
strong advantages of one tool over the other.
Thus, the International Society of Arthroplasty Registries (ISAR) does not make specic recommendations
10
5
0
The worst health
about the preferred general health PROMs tool (Rolfson etal. 2016).
12.2.3 The Patient-Reported Outcomes
Measurement Information System
(PROMIS)
In 2004, a group of US scientists, statisticians, and psychometricians received funding from the National
Institute of Health (NIH) and initiated a multicenter
cooperative group referred to as the Patient-Reported
Outcomes Measurement Information System (PROMIS)
128
PF CAT T-score (adjusted mean)
63% 89%
1-year
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A. Saleh and D. Nam
12
(Cella etal. 2007). The goal of this initiative was to build
and validate common, accessible item banks to measure
key symptoms and health concepts applicable to a range
of conditions, enabling efcient interpretation of clinical trials.
PROMIS consists of item banks organized into
domains of health, such as physical health and mental
health. PROMIS measures can be administered as static
“short forms” similar to those available for other measures, but also can be administered dynamically on a
computer (Fries etal. 2014). Administration via computer involves a highly accurate computerized format
called computerized adaptive testing (CAT), in which a
computer algorithm customizes item delivery to an
examinee by selecting each subsequent item based on
answers to previous items. This way the CAT software
enables a high level of precision using fewer questions.
This CAT provides a key advantage of PROMIS that
distinguishes it from many conventional patientreported measures. One study estimated the MCID for
the physical function component of PROMIS CAT to
be around 7.9 (Hung etal. 2018).
In relation to total joint arthroplasty, the most relevant components are physical function, pain intensity,
and pain interference. The performance of PROMIS in
TKA literature has shown mixed results. Shim et al.
evaluated the responsiveness of PROMIS in ve
domains, which are as follows:
5 Physical function.
5 Fatigue.
5 Pain.
5 Emotional distress.
5 Social health (Shim and Hamilton 2019).
They found the physical health domain to have the best
internal and external responsiveness (positive correlation
with OKS), but the mental health component showed
poorer discriminatory ability. They concluded that the
PROMIS-10 Physical health tool offers superior responsiveness to change compared with the EQ5D in
TKA.Padilla etal. attempted to correlate PROMIS CAT
to joint-specic outcome measures, such as the Knee
Injury and Osteoarthritis Outcome Score (KOOS- JR)
(Padilla etal. 2019). The authors found a modest to strong
correlation (ranging from 0.56 to 0.71), indicating that the
role of PROMIS in capturing joint-specic changes can be
limited after TKA.Kagan etal. sought to characterize the
recovery curve for TKA patients using the physical function and pain interference domains of PROMIS CAT
(Kagan etal. 2018). In 91 patients enrolled in the study,
they found the greatest magnitude of improvement in
both physical function and pain interference had occurred
within the rst 3months. After 6months, patients might
expect modest improvements (.
Fig. 12.2). Stiegel etal.
reported their early experience with using PROMIS to
predict patients who would achieve MCID (Stiegel etal.
. Fig. 12.2 a The change in PROMIS physical function (PF)com-
puterized adaptive test (CAT) in the rst year after TKA. b The
change in PROMIS pain interference (PI) computerized adaptive
46 48
38 40 42 44
Preoperative
6-week 3-month
PF CAT T-score
6-month
lb/ub
test (CAT) in the rst year after TKA. (Reproduced from Kagan
etal. (2018), with permission from Elsevier)
68% 90%
PI CAT T-score (adjusted mean)
1-year
Patient-Reported Outcomes inTotal Knee Arthroplasty
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45 50 55 60 65
Preoperative
6-week
3-month 6-month
PI CAT T-scorelb/ub
129
12
. Fig. 12.2 (continued)
2019). Using the PROMIS short forms print-outs, they
found that 68% of TKA patients met the MCID for pain
interference, 28% for physical function, and 14% for
depression at the 6-week postoperative visit. Although the
authors concluded that preoperative PROMIS can reliably predict achieving the MCID after TKA, the area
under the curve (AUC) for predicting physical function
and pain interference was 0.7 and 0.68, respectively, indicating less than ideal accuracy.
> Further research is necessary to describe the reliabil-
ity, validity, and responsiveness of PROMIS in TKA.
12.2.4 Press Ganey
Press Ganey is the nation’s largest provider of tools for
patient satisfaction measurement and analysis. The survey simply known as the “Press Ganey Survey” has
become the most commonly used survey of outpatient
satisfaction in the United States (Graham etal. 2015).
The survey is used by health care administrations as a
metric assessing various aspects of health care delivery
such as wait times in clinic, and the patient–provider
interaction. Care satisfaction surveys such as the Press
Ganey Survey are increasingly being used as a metric in
performance-based compensation for both hospitals
and health care providers (Holzer and Minder 2011).
The Press Ganey Outpatient Medical Practice Survey
consists of over 20 questions divided into several subdomains such as:
5 Access.
5 Moving through your visit.
5 Nurse or assistant.
5 Care provider.
5 Personal issues.
5 Overall assessment of the practice.
Each question measures responses on a Likert scale
ranging from 1 (indicating very poor) to 5 (indicating
very good). Responses are converted into a 0–100-point
scale, and the mean overall score for all answered questions within an individual subdomain is used to calculate the score for that subdomain. The unweighted mean
of the six subdomain scores is then used to calculate the
mean overall care satisfaction score.
> It is important to understand the contrast between
satisfaction as it relates to the outcome of care and
satisfaction with the process of care (Graham et al.
2015).
Situations arise in which the outcome of a TKA is considered successful by both the patient and the surgeon,
but the process of care is considered to be unsatisfactory
because of cost, inconvenience, or hardship related to
receiving that care.
> Care satisfaction scores, such as the Press Ganey,
have yet to be validated as a true measure of health
care quality in relation to actual patient outcomes.
130
A. Saleh and D. Nam
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Kohring et al. evaluated the correlation between Press
Ganey Outpatient Medical Practice Survey collected
from outpatient clinical encounters and PROMIS CAT
collected preoperatively and postoperatively (Kohring
etal. 2018). They found no correlation at all time points
(Spearman correlation coefcient—0.13–0.18). The
authors question the utility of these scores as surrogate
measures of health care quality, especially when reimbursements become tied to these metrics. Chughtai etal.
also found no correlation between Press Ganey Survey
results with several validated patient-reported outcomes
after TKA, such as SF-12, Knee Society Score, or Western Ontario and McMaster Universities Arthritis Index
(Chughtai etal. 2017).
12.2.5 Prediction Model forPatient
Satisfaction (PMPS)
A recent Prediction Model for Patient Satisfaction was
developed by Van Onsem etal. with the goal of predicting patients’ postoperative satisfaction with high sensitivity and positive-predictive value (Van Onsem et al.
2016). They analyzed ve commonly used patient-
reported outcomes (KOOS, EQ-5D, OKS, PCS, andKSS), and identied ten questions, which when answered
preoperatively could predict patient satisfaction as measured by the 2011 Knee Society Score (KSS). Their
model had a sensitivity of 97% and a positive-predictive
value of 93%. Since their data came from 113 patients at
a single center, Calkins etal. sought to externally validate their model in a new patient sample (Calkins etal.
2019). In this external validation cohort, PMPS failed to
predict any of the 12 dissatised patients and falsely predicted dissatisfaction in 4 patients with maximum postoperative KSS.
> Further research is needed to rene and validate this
prediction model.
12.3 Joint-Specic Outcome Measures
12.3.1 Western Ontario andMcMaster
Universities Osteoarthritis Index
(WOMAC)
The Western Ontario and McMaster Universities
Arthritis Index (WOMAC) is arguably the most widely
used joint-specic outcome measure. It has been extensively validated and translated and linguistically vali-
dated in over 60 alternative-language forms (Angst etal.
2001; Wolfe and Kong 1999; Bae etal. 2001). The valid-
ity, reliability, and responsiveness of the WOMAC were
originally demonstrated by Bellamy etal. in the context
of a randomized controlled clinical trial of two nonsteroidal anti-inammatory drugs in patients with hip and
knee osteoarthritis (Bellamy etal. 1988).
The WOMAC consists of the following three sub-
scales:
5 Pain.
5 Stiffness.
5 Physical function.
The score is interpreted from a best-to-worst scale, in
which lower values indicate less pain and higher function. The scores can be normalized, with 0 indicating
severe symptoms, and 100 indicating no symptoms. The
minimal clinically important difference for the WOMAC
was reported to be 12% of the baseline score or 6% of
the maximum score in a study that examined rehabilitation intervention in osteoarthritis (Angst etal. 2001). A
minimal clinically important difference of 9–12 points
(on a scale of 0–100) has also been reported (Ehrich
etal. 2000).
> The use of WOMAC is recommended in all clinical
studies evaluating TKA outcomes.
12.3.2 Knee Injury andOsteoarthritis
Outcome Score (KOOS)
Since the WOMAC was mostly focused on the elderly,
its utility in younger patients has been questioned as it
is likely to have ceiling effects in this group. The KOOS
was created from the WOMAC as a result of this
proposition (Roos et al. 1998, 1999; Roos and
Lohmander 2003). It was created for evaluating sports
injuries as well as the short- and long-term sequelae of
the injury including the risk of developing osteoarthritis after these injuries. The KOOS was the only
joint-specic patient-reported outcome measure
adopted by the Centers for Medicare and Medicaid
Services (CMS) to meet their pay-for-performance
measures (CMS 2019).
This outcome measure consists of 42 self- administered
items distributed over the following 5 domains:
5 Pain.
5 Symptoms.
5 Activities of daily living.
5 Sport and recreation function.
5 Knee-related quality of life.
Patient-Reported Outcomes inTotal Knee Arthroplasty
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12
Each domain is summed and transformed into a score
from 0 (worst) to 100 (best). All WOMAC questions are
included in KOOS in their original form to assess osteoarthritis in older individuals, and therefore a WOMAC
score can be calculated.
> It is thought that the KOOS has utility in active and
young patients undergoing unicompartmental knee
arthroplasty or patellofemoral arthroplasty (Roos
and Lohmander 2003; Paxton and Fithian 2005).
A short-form survey derived from the full KOOS questionnaire was developed by Lyman et al. in order to
improve efciency in reporting TKA outcomes and
reduce questionnaire burden (Lyman etal. 2016). This
KOOS Joint Replacement (KOOS-JR) survey sought to
represent a single domain of “knee health,” combining
pain, symptoms, and functional ability into a single
score. Their study included 2291 from their hospital
knee replacement registry to reduce KOOS to 7 items
using Rasch analysis. The KOOS-JR showed high internal validity against full KOOS, and also excellent external validity in the Function and Outcomes Research for
Comparative Effectiveness in Total Joint Replacement
(FORCE-TJR) (Lyman etal. 2016).
and includes alignment, instability, and range of motion.
The patient-reported subscale includes symptoms, satisfaction, expectation, and functional activity items. The
higher the score, the better the outcome in all subscales.
> What is unique regarding the patient-reported sub-
scale is that it includes both advanced activities and
three self-selected activities of greatest importance to
the individual patient.
Giesinger etal. evaluated the responsiveness of the KSS
(Giesinger etal. 2014). They reviewed prospective data
from 98 patients and found the KSS to have the largest
effect size from preoperative to 2-month and 1-year follow up, and therefore more responsive in comparison to
generic health outcome tools. Scuderi etal. developed a
short-form version of the new KSS using the same
patient sample used in the long-form of KSS in 2012
(Scuderi etal. 2016). Their proposed short-form reduced
satisfaction items from 5 to a single item, and reduced
functional activities items from 17 to 6. This short-form
correlated well with the original longer form and was
capable of discriminating clinically different groups of
patients before and after TKA with virtually the same
estimated effect size.
12.3.3 Oxford Knee Score (OKS)
The OKS was developed from interviews with patients
to measure outcomes after TKA (Murray etal. 2007;
Dawson etal. 1998). It is a 12-item survey, assessed on a
Likert scale with values from 0 to 4; a summative score
is then calculated where 48 is the best possible score. In
the above-mentioned study by Shim etal., OKS had the
greatest responsiveness to change after TKA when compared with general health outcome measures such as
EQ-5D and PROMIS-10 (Shim and Hamilton 2019).
Clement etal. reported an MCID of 5 (Clement etal.
2014).
12.3.4 Knee Society Score
In 1989, the original Knee Society Score (KSS) was
developed as an objective tool to rate the patient’s functional abilities (Insall etal. 1989). In an era where patient
satisfaction is key, the original KSS was criticized as
being a surgeon-assessed questionnaire, and its utility
was challenged in contemporary patients who have
expectations and demands. In 2012, the Knee Society
published a new scoring system that is both physicianand patient-derived (Scuderi et al. 2012; Noble et al.
2012). The objective score is completed by the surgeon
Take-Home Messages
5 Patient-reported outcomes are particularly cru-
cial in measuring the results of “elective” procedures such as TKA because patient-reported
outcomes take into account the more subjective
issues of expectations and preferences.
5 Patient-reported outcomes are generally
described as generic quality-of-life measures
(e.g., SF-12 and EQ-5D) or joint-specic measures (e.g., KOOS, OKS, or KSS).
5 SF-36, SF-12, EQ-5D, WOMAC, KOOS, KSS,
and OKS are among the most published and
validated outcome measures.
5 Further research is required to validate PRO-
MIS in TKA.
5 Arthroplasty surgeons should be familiar with
the different measures available to help improve
future study design and incorporate meaningful
ndings in their clinical practice.
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Treatment
https://t.me/medicina_free
Contents
Chapter 13 Fixation in Joint Arthroplasty – 137
Michael Morlock, Sarah Fischer, and Elke Lieb
Chapter 14 Medial Unicompartmental Knee Arthroplasty – 143
Asim Khan and Fares Haddad
Chapter 15 Lateral Unicompartmental Knee Arthroplasty – 155
Neel R. Patel, Keith R. Berend,
and Adolph V. Lombardi Jr.
Chapter 16 Lateral Unicompartmental Knee Arthroplasty:
A French Perspective– 173
Axel Schmidt, Christophe Jacquet, Matthieu Ollivier,
and Jean-Noël Argenson
135
IV
Chapter 17 Patellofemoral Arthroplasty – 187
Simon Garceau, William J. Long, and Ran Schwarzkopf
Chapter 18 Bicompartmental Knee Arthroplasty – 199
Michael D. Ries
Chapter 19 Total Knee Arthroplasty – 209
Alex Lencioni and Craig A. Hogan
Chapter 20 Patellar Resurfacing in Cemented Total Knee
Arthroplasty – 221
Sachin Allahabadi and Derek Ward
Chapter 21 Patella Replacement in Knee Arthroplasty:
A Japanese Perspective – 233
Atsushi Takahashi
Chapter 22 Knee Arthroplasty: An Asian Perspective – 245
Wilson Wang, Bryan T. H. Koh, and Vikaesh Moorthy
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