Abstract

Total knee arthroplasty or TKA, is a form of knee replacement for individual who suffer

damage due to arthritis/osteoarthritis. In order to understand which patients will benefit the most

from TKA, there are standardized scores that demonstrate patient efficacy. The main test being

the Knee and Osteoarthritis Outcome Survey, Joint Replacement (KOOS, JR) and Patient

reported outcomes. Using this test a MCID (minimal clinical difference) is determined

comparing these metrics pre-operatively and postoperatively. By understanding this we can see

which patients will have the best outcomes, which can determine how resources are used and

where.
Timeline expectations for MCID:

Darrith et. al, 2021 found that although the KOOS-Jr has been effective another metric,

the Patient-Reported Outcomes Measurement Information System and Global Health scores

(PROMIS-GH) is used equally as well. PROMIS -GH consists of ten items on 5 point scale

regarding physical and mental health. The study by Darrith et. al, 2021 found that the PROMIS-

GH score “was the only test to be significantly associated with postoperative PROMIS-PH

scores at 1, 6, and 12 months postoperatively on multivariable regression analysis”. Other test

variables such as patient demographics, comorbidities or lab variables were significantly

associated with predicting a change in the PROMIS-GH scores. Within the study, MCID was

calculated as a change of 2.3 (pre- to post-operation) for PROMIS-GH, and 6.8 for the KOOS-JR

test. But data was adjusted to include the demographic and patient specific data, which altered

the AUC (area under curve) resulting in higher predictive value for the PROMIS-GH (0.79)

compared to the KOOS-JR (O.75). Accurate surveys are crucial for determining candidates and

patients who will have the most success from operations or are most at need.

Lafi et. al conducted a similar study in 2020 comparing the PROMIS-GH and KOOS-JR

score pre- and post-operatively through 12 months. The study found there to be a positive

correlation between the PROMIS-PH and KOOS-JR score, as there was an increase at each

postoperative time point (1, 3, 6 months and 1 year). PROMIS-PH was found to have moderate

increases at 1 and 3 month and excellent at 6 and 12 months. However, it was found that the

KOOS-JR test had “excellent” responsiveness at all 4 time points. In the end the MCID was
found to be 2.3 for PROMIS-PH and 2.5 for the KOOS-JR. PROMIS-PH scores of less than or

equal to 38 predicted MCID at least within 1 year (70% specificity) and PROMIS-PH score of

less than 32.5 resulted in MCID for 79/86 patients who achieved the MCID. Timeline for

improvement is important in guiding clinical decision making, especially if larger improvements

are much later after operation.

Kagan et. al, 2018 sought to investigate the typical recovery in physical function (PF) and

pain (PI) using PROMIS and patient reported outcomes (PRO). PROMIS and PRO were

obtained preoperatively and postoperatively at 6 weeks, 3 months, 6 months, and 1 year.

Responsiveness at 6 weeks was poor as there was no significant difference or MCID. However,

at the other three time points, PROMIS PI score was statically greater than preoperative scores.

The largest difference in score occurred at 3 months. The MCID for PROMIS-PF was 3.34 while

PROMIS-PI was 4.43. Appropriate timing can help direct clinical guidelines about the expected

time for symptom/lifestyle improvement.

Austin et. al, 2019 explored whether a one question patient reported outcome can be as

effective PROMIS-10/KOOS-JR evaluations for determining MCID in TKA. The one question

report in the Modified-SANE report (M-SANE), asked patients to report their knee function on a

scale of 1-10. Then they also completed the KOOS/PROMIS survey to compare. In 2017, 217

patients completed the M-SANE pre- and post-operatively at 1 year. Preoperatively the average

M-SANE score was 3.5 and saw an increase to an average of 6.6 post operatively with an MCID

of 1.52. Both the KOOS-JR and PROMIS-PCS were found to increase over treatment course and

have a strong relationship. The Ro values were (ρ = 0.65, P < .001) and (ρ = 0.65, P < .001). The
relationship was much stronger with the post operative outcomes. Timing is an important factor

in determining clinical benefit, survey type can be factor in the time course/perceived benefit.

Accurate MCID value:

Soh et. al 2022 conducted a study in which they looked at both KOOS-JR and HOOS-JR

scores (for hip replacement) to compare their pre and post operative outcomes at 6 months. A 12-

item score was used looking at 3 important areas: pain function and quality of life. At 6 months

post operative there was a significant increase for both HOOS and KOOS-JR scores. The MCIC

for KOOS-JR was defined as an increase of at least 14.2-16.2 points. These differences in score

are attributable to difference in calculating the MCID (distributive vs anchored). A higher value

may also be due to specific patient/population needs.

Lyman et. al, 2018 were concerned with the validity of the MCID was for TKA patients

and the appropriate value/range was. MCID was compared using distribution and anchor-based

methods and compared to the minimal detectable change (MCD) for KOOS-JR scores in TKA

patients. The anchor method depended on an “anchor question” which was asked at follow up,

which help determine patients who had a change in their health. Whereas the distribution method

just assumes a normal distribution of 0.5xSD. MCD was defined as “the minimal amount of

change required to distinguish a true health change from variability resulting from measurement

error”. Study was conducted from 2007-2012 and surveys were recorded preoperatively and 2

years post operatively. Using the distribution-based approaches, MCID ranged from 6-9, whereas
MCID ranged from 7-36 for the anchor-based methods. The distribution approach method was

not appropriate because the MCID value that was calculated smaller than the MCD, meaning it is

not a valid measure. Therefore, the properties of the MCID (anchor vs distribution) need to be

taken into consideration when creating the survey/metric.

Naylor et. al, 2014 aimed to assess the actual value of the MCD and its coefficient of

variation. The study retested the MDC95, six-minute walk test, timed up and go test and KOOS

scores. KOOS pain was reported 20.2, symptoms 24.1 and quality of life 26.6. The MCID for

KOOS pain was 20, 24 for symptoms, 21 for KOOS-ADL and 27 for KOOS-QOL. Most notable

it was noted that the 6MWT had the smallest error in measurement, therefore had the best ability

to detect the smallest real change in a clinical setting.

Eckhard et. al, 2021 then tried to establish what the important change and MCID values

of the KOOS-12 survey were after TKA. They collected KOOS-12 scores preoperatively and 1

year postoperatively. Minimally important change values were established using anchor-based

methods. They also defined the MCID as “the mean change in the KOOS-12 between the ‘no

improvement’ and ‘little improvement’ groups”. Out of total 352 patients 97.1% reported

“important improvement”. The MIC was established at “11.5 for Pain, 13.7 for Function, 5.5 for

Quality of Life (QoL) and 14.9 for the total KOOS-12 score”. The MCID values were 13.5 for

Pain, 15.2 for Function, 8.0 for QoL and 11.1 for the total KOOS-12 score. Range of MCID
values can be important value in determining which patients have favourable outcomes and

improvements post TKA.

Machine learning to predict outcomes

Fontana et. al 2019 explored whether machine learning could help identify patients who

were not likely to have significant improvement from total joint arthroplasties. They explored

programs that could help increase the predictive capabilities of these machines. Predictors were

based on four categories 1.) Before decision: focusing on BMI, years of education, years of pain

medication use. 2.) Before surgery: KOOS/PROMIS, number of procedures. 3.) Before

discharge: time in the OR, number of procedures on surgery day 4.) After discharge: Length of

stay, number of procedure code/diagnosis codes after stay. These algorithms performed in a poor

to good range achieving an AUC of 0.60-0.89. The before surgery models of group 2 were found

to have performed the best. Preoperational surveys appear to still have a strong predictive value

of operation outcomes. This highlights the effectiveness common pre-operative methods to

determine efficacy.

Importance of survey completion to determine patient efficacy:

Molloy et. al 2019 researched a different topic. They conducted a study into whether

Medicare patients PROMIS collections reflected academic medical practice. A retrospective

analysis of THA/TKAs were collected from a 2017 cohort who completed the PROMIS survey

pre and post operatively. The recommended completion of the pre-operative survey was 90-0

days while the recommended post operation completion time is 270-365 days. Completion rates

of the surveys were then assessed. 725 or 84.3% of preoperative surveys were completed within

the desired time whereas only 215 (29.7%) completed the postoperative survey. The importance
of the survey completion can help determine severity pre-operation and efficacy post operation

as well as the timeline when major change or increase in post-surgery outcomes can be expected.

Factors affecting MCID:

Katakam et. al, 2019 discussed whether obesity/BMI is risk factor preventing TKA

patients from achieving a MCID on the PROMIS-PF survey (done preoperatively and

postoperatively) and whether BMI threshold for success exists. Subgroups were broken into 4

classes “Obese Class I” (30-35 kg/m2), “Obese Class II” (35-40 kg/m2), and “Obese Class III”

(>40 kg/m2) compared to “Normal BMI” (<25 kg/m2). Across all subclasses there was an

increasing rate of failure to reach PROMIS-PF-10a MCID, with increasing BMI. The regression

analysis also stated that increasing BMI is “significantly associated with failure to meet the

PROMIS PF-10a MCID; specifically, an increase in 1 kg/m2 increased the risk of failure to

achieve the MCID by 2%”. In the three obese subclasses failure to reach MCID was increased

with increasing BMI at 27%, 51%, 64% respectively. The PROMIS-PF survey was also the only

test preoperatively that was able to be “significantly predictive” of failure to achieve MCID.

Weight appears to be a large factor in determining TKA success.

Goh et. al, 2022 attempted to understand the “Paradox of patient reporter outcome

measures” as they related to TKA. They assessed factors that impacted the MCID and patient

acceptable syndrome state (PASS) on PROMIS/KOOS-JR surveys for patients who underwent

TKA. Of the 1239 patients who underwent TKA the pre and post operation scores were 48.3 and

74.1 respectively. In the one year follow up 883 patients (71.3) achieved the MCID (determined

to be 14.0 taken from another study) and 936 patients achieved the PASS (75.5%). 788 achieved
both MCID and PASS (63.6%). 95 patients (7.7%) met MCID but not PASS and 148 patients

(11.9%) met the PASS but not MCID. It was found patients with poorer pre operation

scores/function were more likely to achieve MCID but those with the best preoperative function

were least likely to achieve MCID but most likely to achieve PASS. Age was a large factor,

younger patients reported worse preoperative outcomes and the greater postoperative outcomes

therefore more likely to achieve MCID. Older, white patients with high preoperative scores were

more likely to achieve the PASS. Those who receive the surgery depending on lifestyle, hobbies

or habits will often report very differently and present with differing MCID.

Berliner et. al, 2017 explored the subset of patients who do not experience positive

outcomes from TKA (decreases in pain, increases in physical function/quality of life)

documented in the PROMIS surveys. Patients were assessed preoperatively and 1 year post-

operatively using the KOOS and SF12v2 scores (562 patients total). The MCID was calculated

to be 10 and 5 respectively, using distribution methods. The primary finding was due to the

threshold value set for preoperative KOOS and SF12v2 scores of 58 and 34 respectively. Patients

who were reported scores above this set threshold meant better preoperative function but

consequently were less likely to see much improvement functionally after TKA (or achieve the

MCID). The AUC value of KOOS score (0.76) was higher than the SF12v2 AUC (0.65)

therefore demonstrating high degree of predictability. Patients who saw the greatest likelihood of

achieving the MCID were those with greatest amount of disability (lowest KOOS scores) and

increased mental health status (MCS scores). The SF12v2 becomes more acceptable (AUC 0.71)

when mental health (preoperatively) status is considered. Under these conditions the SF12v2

increased its threshold value by points. The KOOS score also improved in predictability (AUC
0.8) under the same conditions. Predictive capabilities can be influenced by not only physical but

mental health parameters, which can increase their predictive capability.

Discussion:

From the literature we have learned many things we can apply to future TKAs. With

regards to expected timelines for observable effects/clinical difference, postoperatively there is

some delay. MCID increase after a minimum of 3 months. In follow ups 6 months and onward

there is clinically significant increases in MCID through KOOS/PROMIS scoring. This can be

important in helping clinicians decide which patients will benefit most from TKA. If timing due

to patient concerns is an issue due to illness or other issues surgery can be delayed or alternative

methods sought after. Also, this can be very important in managing patient expectations, helping

ease individuals, which may reflect in more consistent post-operative scoring.

To understand the KOOS/PROMIS MCID scores there has to be some consistency.

Finding a value that is clinically useful has been long researched. MCID values generally have

been found to within the 10–20-point range. Despite this there have been some studies with the

MCID below ten (Darrith et. al 2021, Lafi et. al 2020). This can be due to differences in

determing the MCD (distributive/anchor based). More research needs to be conducted regarding

which method clearly can be predictive of efficacy of TKA. The anchor method alone was found

to be more predictive as it was based on a single question about efficacy. Use was found to be on

par with MCID for KOOS/PROMIS scoring, more sources or research should be undertaken

regarding the anchor method for MCD.

 In determining which patients will have the best outcome/most likely to achieve MCID

some clear conclusions have been made. Obesity is a major factor, as those with increasing BMI

were increasing less likely to achieve MCID with increasing BMI. Age was another factor. We

can infer those who are younger or activity status (athletes, active hobbies etc.) would have

lower scores on KOOS/PROMIS survey which would explain why they were more likely to

achieve an MCID. Conversely those who were older, possibly more affluent would report lower

MCID due to a more sedentary life, not being more active post TKA.

We can clearly see that the methods that are in place are effective at predicting MCID.

Factors can be influenced by different factors (age, BMI, activity status etc.). These factors need

to be considered when constructing the MCID (anchor vs distributive). With this knowledge we

know those with lower preoperative scoring are more likely to achieve the MCID, which is

general setting around 9–13-point increase in postoperative scores. This value is not standardized

which should a be point of emphasis moving forward. From this we can determine with some

accuracy which patients will have the greatest benefit from TKA. This is helpful for clinicians.

Surgery is costly and time consuming. Knowing the timeline for recovery along with specific

patient attributes we can focus resources on those who have the most need and will have the

most benefit, aiding our practice.

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