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EDITOR’S CHOICE

Comparison of the Michigan Hand


Outcomes Questionnaire, Boston Carpal
Tunnel Questionnaire, and PROMIS
Instruments in Carpal Tunnel Syndrome
Bilal Mahmood, MD,* Chen Chongshu, MA,† Xing Qiu, PhD,† Susan Messing, MA, MS,†
Warren C. Hammert, MD*

Purpose Patient-reported outcomes are important to assess improvement after surgery.


Common instruments for carpal tunnel syndrome include the Michigan Hand Outcomes
Questionnaire (MHQ) and Boston Carpal Tunnel Questionnaire (CTQ). The Patient-Reported
Outcomes Measurement Information System (PROMIS) are newer measures. We evaluated
how the PROMIS Pain Interference (PI) and Upper Extremity (UE) scores change after carpal
tunnel release.
Methods All adult patients with carpal tunnel syndrome treated surgically were asked to
participate in this prospective study. PROMIS instruments, MHQ, and CTQ were completed
by 101 patients. Estimated means and standard errors were calculated, and piecewise linear
fixed effects regression models were applied to the data. Standardized response means were
calculated for each outcome measure.
Results The MHQ Total Score did not show a considerable change from the preoperative to
1-week postoperative visit but improved from the 1-week to 3-month postoperative visit (55
to 80). The CTQ Functional Status Score (FSS) worsened from 2.3 preoperatively to 2.6 at the
1-week postoperative visit before improving through the 3-month postoperative visit (1.6).
PROMIS UE showed responsiveness similar to the CTQ FSS with a decline at the 1-week
visit, 38 to 33, followed by improvement (45 at 3 mo). However, the standardized
response mean values were greater for the CTQ FSS compared with PROMIS UE. The
average administration time was shortest for PROMIS UE. The CTQ Symptom Severity Scale
and MHQ Pain Scores showed improvements as early as the 1-week visit. The CTQ Symptom
Severity Scale improved from 3.1 to 2.3, and MHQ Pain Scores improved from 55 to 46.
PROMIS PI did not change at the 1-week visit but improved at 6 weeks and 3 months, from
56 to 52 and 49. The standardized response means for PROMIS PI achieved a large effect size
only at 3 months.
Conclusions The CTQ FSS is more responsive than PROMIS UE and the MHQ, with the CTQ
FSS showing the largest effect sizes. PROMIS PI does not show the responsiveness seen in
the CTQ Symptom Severity Scale and MHQ Pain Score. PROMIS instruments require less
time to complete.

From the *Department of Orthopaedics and Rehabilitation; and the †Department of Corresponding author: Warren C. Hammert, MD, Department of Orthopaedics and
Biostatistics and Computational Biology, University of Rochester, Rochester, NY. Rehabilitation, University of Rochester, 601 Elmwood Ave, Box 665, Rochester, NY 14642;
e-mail: Warren_Hammert@urmc.rochester.edu.
Received for publication September 28, 2017; accepted in revised form October 30, 2018.
0363-5023/18/---0001$36.00/0
No benefits in any form have been received or will be received related directly or indirectly https://doi.org/10.1016/j.jhsa.2018.10.031
to the subject of this article.

Ó 2018 ASSH r Published by Elsevier, Inc. All rights reserved. r 1


2 PROMIS COMPARED WITH MHQ AND BOSTON CTQ IN CTS

Clinical relevance This study demonstrates the change in PROMIS scores after carpal tunnel
release and how they compare with legacy outcome instruments. (J Hand Surg Am. 2018;-
(-):-e-. Copyright Ó 2018 by the American Society for Surgery of the Hand. All rights
reserved.)
Key words Carpal tunnel syndrome, patient reports outcomes, PROMIS.

extensively.10e13 PROMIS instruments provide a set

P
ATIENT-REPORTED OUTCOME measures are
becoming increasingly important to assess of measures in various domains to assess physical,
improvement after surgery. Their use is also mental, and social health. PROMIS Physical Func-
expanding beyond the purpose of clinical research tion (PF) and Upper Extremity (UE) have already
and is entering into routine clinical care in many been shown to strongly correlate with Quick Dis-
practices. Commonly used patient-reported outcome abilities of the Arm, Shoulder, and Hand, and some
measures include the Disabilities of the Arm, authors have recommended PROMIS PF to be used
Shoulder, and Hand questionnaire, the Michigan as a UE outcome measure.14,15 PROMIS UE includes
Hand Outcomes Questionnaire (MHQ), the Boston self-reported capabilities of the UEs only, in com-
Carpal Tunnel Questionnaire (CTQ), the Patient- parison with PROMIS PF, which also includes the
Rated Wrist Evaluation, and the Cold Intolerance lower extremity. They are highly correlated with each
Severity Scale.1e4 One all-encompassing outcome other and the Disabilities of the Arm, Shoulder, and
measure is not realistic, but as new measures are Hand.14e16
introduced, they must be evaluated for responsive- The purpose of this study was to compare
ness, sensibility, reliability, and validity. Once these PROMIS PF, PI, and UE scores, as well as the MHQ
criteria are met, new measures may have advantages and CTQ scores preoperatively, and at 1 week, 6
with respect to efficiency and feasibility. weeks, and 3 months after CTR. The secondary goal
The Patient-Reported Outcomes Measurement In- was to compare the time with completion of each
formation System (PROMIS) instruments are measures instrument.
designed to assess various health domains. PROMIS
was developed, beginning in 2004, as part of an NIH
initiative called the Roadmap for Medical Research. MATERIALS AND METHODS
PROMIS uses computerized adaptive testing (CAT) PROMIS PF, UE, and PI (version 1) scores, as well
based on item-response theory to decrease administra- as MHQ and CTQ scores, were collected prospec-
tion time while maintaining accuracy. CAT changes tively between November 2014 and October 2016 on
upcoming test items based on respondent answers to all patients presenting to an academic medical center
prior items, thus allowing for calculating scores with a hand surgery practice and who agreed to participate
minimum number of questions. PROMIS is being in the study. We obtained approval for this study
adopted into electronic medical records, allowing for from our institutional review board, and informed
real-time tracking of outcomes. The American Board of consent was obtained from each participant before
Orthopaedic Surgery requires inclusion of PROMIS entering the study. An a priori sample size estimate
scores as a component of their Part II certifying ex- calculated 54 patients were needed for 90% power to
amination. In various areas of orthopedics, preoperative detect changes of a large Cohen’s effect size in
PROMIS scores in the domains of physical function, PROMIS PF. Given that PROMIS scores are based
pain interference (PI), and mental health have proven on population norm T scores, with 50 being the
successful in predicting outcomes after surgery.5e7 average and standard deviations set at 10 across
PROMIS has also shown changes in physical domains, this calculation would be accurate for other
function postoperatively after anterior cruciate PROMIS instruments as well. Patients asked to
ligament reconstruction captured with gait analysis participate in the study were diagnosed with CTS,
studies, but not detected by the Internal Knee based on history, physical examination, and electro-
Documentation Committee scale.8 diagnostic studies, and elected to have carpal tunnel
Carpal tunnel syndrome (CTS) is one of the most surgery. Exclusion criteria were patients younger than
common disorders treated by hand surgeons.9 The 18 years of age, those who were unable to speak or
CTQ is the most sensitive instrument for CTS, but read English, or give informed consent, or having a
both the CTQ and MHQ are responsive to changes surgical procedure in addition to CTR. Some patients
after carpal tunnel release (CTR) and have been used were not willing to participate because of the time

J Hand Surg Am. r Vol. -, - 2018


PROMIS COMPARED WITH MHQ AND BOSTON CTQ IN CTS 3

required to complete the questionnaires, need to re- piece from the 1-week to 3-month postoperative visit.
turn for the 3-month data, or other reasons, resulting This method was chosen after noting an initial func-
in a final cohort of 101 patients who completed the tional decline after surgery, followed by a predictable
study. Data were collected at the preoperative visit, improvement. The initial piece from the preoperative
and at 1-week, 6-week, and 3-month postoperative visit to the 1-week postoperative visit was kept in the
visits. analysis because we determined that some outcome
The PROMIS instruments were accessed at the measures may not capture this early decline, and this
Assessment Center (www.assessmentcenter.net), would provide another point of comparison for
including the PF, PI, and UE scales. PROMIS PROMIS and the legacy measures. SRM is a unit-free
scores are reported as T scores standardized to a method used to directly compare different instruments,
normative US population with 50 representing the with 0.2 to 0.49 considered a small response, 0.5 to
average in a population and each standard deviation 0.79 as a moderate response, and 0.8 or greater as a
being 10 points. Higher PROMIS scores indicate large response in measuring responsiveness.10 Time to
more of the domain evaluated. Thus, a higher administer and complete PROMIS UE and PI at the
PROMIS PF and UE score indicates increased preoperative visits was compared with CTQ and MHQ
function, whereas a high PROMIS PI score in- using paired t tests.
dicates increased PI. The MHQ consists of 6 sub-
scale scores, each ranging from 0 to 100. These
include hand function, activities of daily living, RESULTS
pain, satisfaction, aesthetics, and work performance. A total of 101 patients agreed to participate in the
A total combined score is calculated for overall study. The results of PROMIS PF, PROMIS UE
function. Each of the domains has been shown to be (version 1), MHQ Total Score, and CTQ Functional
valid and reliable independently, with a higher score Status Score (FSS) are shown in Table 1.
indicating more of that condition. Of these, a higher The PROMIS PF did not show a statistically sig-
score for pain is worse and for all other domains, is nificant change between the preoperative visit and the
better.17 1-week postoperative visit (47 and 46; P ¼ .13). It
The CTQ evaluates symptom severity and func- did show a statistically significant improvement from
tional status; each domain is scored from 1 to 5, with 1 week postoperatively to 6 weeks and 3 months
higher scores representing greater symptom severity postoperatively (P < .05), although the absolute
or greater functional difficulty. improvement was modest with 6-week postoperative
The mean, standard deviation, standard error, and and 3-month postoperative scores at 49 and 48,
95% confidence interval for each mean were calcu- respectively. The SRM reached a small response only
lated for PROMIS PF, PI, UE, as well as for total at the 3-month postoperative visit, with a value of
score, MHQ Pain Score, CTQ Symptom Severity 0.28. PROMIS UE showed a significant decline in
Scale, and the CTQ Functional Status Scale. These patient function from the preoperative visit to the
were calculated for the preoperative, 1-week post- 1-week postoperative visit (38 to 33; P < .05), which
operative, 6-week postoperative, and 3-month post- is moderate responsiveness with a value of 0.68.
operative visits. Standardized response means (SRM) After this, there was a significant improvement from
were also calculated for each of these scores at each the 1-week postoperative visit through the 3-month
time point. The SRM is defined as the difference of postoperative visit with P < .05, measuring 41 at 6
the means at 2 time points divided by the standard weeks postoperatively and reaching 45 at 3 months
deviation of the mean difference. The time to postoperatively. The SRM reflected moderate
administer and complete PROMIS PF, PI, and UE, as responsiveness. Figures 1 and 2 show PROMIS
well as CTQ and MHQ was also recorded for each PF and PROMIS UE means with 95% confidence
time point, and the mean, standard deviation, stan- intervals for each visit, respectively.
dard error, and 95% confidence interval were The MHQ Total Score did not show a statisti-
calculated. cally significant change between the preoperative
Piecewise linear fixed effects regression models and 1-week postoperative visits (55 for both),
(using 2 pieces) were used to determine notable but did show significant improvements from the
changes in the temporal direction for each outcome 1-week postoperative through the 6-week and
measured as this allows different rates of change.18 The 3-month postoperative visits (73 and 80) with a
first piece consisted of the scores from the preoperative clear improvement noted (P < .05) (Fig. 3).
visit to the 1-week postoperative visit, and the second The SRM showed a large response at the 6-week

J Hand Surg Am. r Vol. -, - 2018


4 PROMIS COMPARED WITH MHQ AND BOSTON CTQ IN CTS

PROMIS Physical Funcon Score

Response Mean
52

Standardized
3-Month

0.28
0.66
1.26
0.90
50

48

46

44

CI, confidence interval; CTQ, Carpal Tunnel Questionnaire; MHQ, Michigan Hand Outcomes Questionnaire; PROMIS, Patient-Reported Outcomes Measurement Information System.
Mean (95% CI)

42
1.6 (1.4e1.8)
Postoperative

48 (46e50)
45 (42e48)
80 (76e85)
3-Mont

40
Preoperave 1-week 6-weeks 3-months
Postoperave Postoperave Postoperave

FIGURE 1: PROMIS physical function scores showing a statis-


tically significant improvement from 1 week postoperatively
through 3 months postoperatively.
Response Mean
Standardized
6-Week

0.17
0.34
1.17
0.60

and 3-month postoperative visit with values of


1.17 and 1.21, respectively. The CTQ FSS had an
early decline in function, represented by a larger
value, from the preoperative visit to the 1-week
Results From PROMIS Physical Function, PROMIS Upper Extremity, MHQ, and CTQ

Mean (95% CI)

1.8 (1.7e2.0)
Postoperative

postoperative visit (2.3 to 2.6; P < .05), with the


49 (47e50)
41 (39e44)
73 (70e77)
6-Week

moderate responsiveness of 0.43. This was fol-


lowed by a statistically significant improvement
from 1 week postoperatively through 3 months
postoperatively to 1.6 (P < .05) (Fig. 4). The SRM
reached a large response at 3 months with a value
Response Mean
Standardized

of 0.90.
1-Week

0.21
0.68
0.06
0.43

The results of PROMIS PI, MHQ Pain Scores, and


CTQ Symptom Severity Scores are shown in Table 2.
PROMIS PI scores (Fig. 5) do not show any signif-
icant change from the preoperative visit to the 1-week
postoperative visit (56 for both). However, there was
Mean (95% CI)

2.6 (2.4e2.8)
Postoperative

46 (44e47)
33 (31e34)
55 (51e59)

a significant improvement in PI between 1 week and


1-Week

3 months postoperatively, 56 to 52 to 49 (P < .05).


The SRM reaches a moderate response of 0.49 at 6
weeks postoperatively and a large response of 0.84 at
3 months postoperatively. The MHQ Pain Scores
showed immediate improvement from the preopera-
Mean (95% CI)

2.3 (2.1e2.4)
Preoperative

47 (45e48)
38 (37e40)
55 (51e59)

tive visit to the 1-week postoperative visit (55 to 46;


P < .05) with a moderate SRM of 0.48. This per-
sisted at 6 weeks and 3 months postoperatively (27
and 17, respectively; P < .05), and large SRM values
of 1.07 and 1.14 were recorded (Fig. 6). Similarly,
the CTQ Symptom Severity showed a statistically
CTQ Functional Status Score

significant improvement throughout the study period,


PROMIS Physical Function
PROMIS Upper Extremity
Outcome Measure

both from the preoperative visit to the 1-week post-


operative visit (3.1 to 2.3; P < .05) and the 1-week
postoperative visit to the 3-month postoperative
MHQ Total Score

visit (2.3 to 1.8 to 1.6; P < .05) (Fig. 7). In this case,
the SRM values at all postoperative visits show a
TABLE 1.

large response, 1.02, 1.62, and 1.69.


The mean time in seconds to complete PROMIS
PF, PROMIS UE, PROMIS PI, MHQ, and CTQ is

J Hand Surg Am. r Vol. -, - 2018


PROMIS COMPARED WITH MHQ AND BOSTON CTQ IN CTS 5

PROMIS Upper Extremity Score CTQ Funconal Status Score


50 3

45 2.5

40 2

35 1.5

30 1
Preoperave 1-week 6-weeks 3-months Preoperave 1-week 6-weeks 3-months
Postoperave Postoperave Postoperave Postoperave Postoperave Postoperave

FIGURE 2: PROMIS upper extremity scores showing a statisti- FIGURE 4: CTQ Functional Status Score showing a statistically
cally significant decline preoperatively to 1 week postoperatively, significant decline in functional ability preoperatively to 1 week
followed by a statistically significant improvement from 1 week postoperatively, followed by a statistically significant improve-
postoperatively to 3 months postoperatively. ment in functional ability from 1 week postoperatively to 3
months postoperatively.

MHQ Total Score postoperatively but shows a greater change at 6 weeks


90
and 3 months postoperatively when compared with
85
both PROMIS UE and CTQ FSS. The responsiveness
80
75
pattern of the MHQ is unexpected, but our study does
70 not provide an explanation for this pattern. It may be
65 considered that, within a narrow range of function, the
60 MHQ is not as sensitive as the PROMIS UE and CTQ
55 FSS, but this would need to be evaluated separately.
50
Preoperave 1-week 6-weeks 3-months
Although it has been shown that PROMIS UE com-
Postoperave Postoperave Postoperave pares favorably with PF,19 in our study, PROMIS PF
did not show the same responsiveness as PROMIS UE
FIGURE 3: MHQ Total Score showing a statistically significant
and CTQ FSS showed.
improvement from 1 week postoperatively through 3 months
postoperatively.
There could be many explanations for a decrease
in scores at an early time point, including surgical
pain and lack of time for improvement. All 4 outcome
shown in Table 3, along with the 95% confidence measures showed an improvement from 1 week
interval, standard deviation, and standard error for postoperatively to 3 months postoperatively. Similar
each calculation. PROMIS PF, UE, and PI were each to our study, Beleckas et al16 demonstrated that
quicker to complete with means of 64 seconds and 57 PROMIS UE is responsive to change over time.
seconds compared with MHQ (465 s) and CTQ (165 However, they noted a ceiling effect at a score of 56,
s, P < .05. CTQ was also significantly quicker to which indicates that in those above this level,
complete, compared with MHQ with P < .05. improvement cannot be discerned using PROMIS
UE. Our data further support this, as we note that the
highest PROMIS UE score in our study was 56.
DISCUSSION Directly related to this ceiling effect is a limitation on
Our study showed that PROMIS UE has similar the PROMIS UE SRM, which only reached moderate
responsiveness to the CTQ FSS in showing a func- responsiveness in our study. It is possible that the
tional decline at the 1-week postoperative visit in pa- questions used in PROMIS UE, as well as the CAT
tients undergoing CTR. However, although both show algorithm, are responsible for this ceiling effect.
considerable improvement at the 6-week and 3-month We showed that PROMIS PI does not have the same
postoperative visit, the CTQ FSS has larger SRM responsiveness as the CTQ Symptom Severity Score or
values, showing a large response at 3 months post- MHQ Pain Scores. This difference is because PROMIS
operatively. PROMIS UE only shows a moderate PI measures interference and does not capture a mea-
response at 6 weeks and 3 months postoperatively. The surement for symptoms in isolation and may also be
MHQ Total Score shows no change at 1 week affected by self-efficacy. Thus, even with carpal tunnel

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6 PROMIS COMPARED WITH MHQ AND BOSTON CTQ IN CTS

PROMIS Pain Interference Score

Response Mean
60

Standardized
3-Month

0.84
1.14
1.69
55

50

CI, confidence interval; CTQ, Carpal Tunnel Questionnaire; MHQ, Michigan Hand Outcomes Questionnaire; PROMIS, Patient-Reported Outcomes Measurement Information System.
Mean (95% CI)

1.6 (1.4e1.8)
Postoperative

49 (47e52)
17 (11e22)
3-Month

45
Preoperave 1-week 6-weeks 3-months
Postoperave Postoperave Postoperave

FIGURE 5: PROMIS Pain Interference Score showing a statis-


tically significant decline in pain interference from 1 week
Response Mean

postoperatively through 3 months postoperatively.


Standardized
6-Week

0.49
1.07
1.62

symptoms improving, PROMIS PI remains unchanged


early on. Caution is advised when interpreting changes
in PROMIS PI as it is not sufficiently responsive in the
first week after CTR. The larger response shown with
Mean (95% CI)

1.8 (1.7e2.0)
Postoperative

52 (50e54)
27 (22e32)

MHQ and CTQ indicates that these legacy measures are


6-Week

more sensitive to changes after the surgical treatment of


CTS.
We demonstrated the benefit of PROMIS instruments
when administered in CAT form in time to administer
Results From PROMIS Pain Interference, MHQ Pain Score, and CTQ

and complete. CTQ was much quicker to complete than


Response Mean
Standardized

the MHQ. This might be expected because the CTQ is a


1-Week

0.02
0.48
1.02

condition-specific tool, whereas the MHQ is a region-


specific measure. Both PROMIS instruments were
quicker to complete than the CTQ, even combining the
time to complete both PROMIS UE and PI. When
evaluating outcomes for a single diagnosis, such as CTS,
Mean (95% CI)

2.3 (2.1e2.5)
Postoperative

56 (55e58)
46 (41e50)

a more specific outcome instrument is preferred, but


1-Week

general outcome instruments have the advantage of


being used across multiple conditions, which makes it
easier to apply to all patients in a practice. In this
instance, differences of 1 to 3 minutes of administration
time may be irrelevant. In clinical settings where all
Mean (95% CI)

3.1 (2.9e3.2)
Preoperative

56 (55e58)
55 (50e60)

patients are required to report patient-reported outcome


measures as part of a routine practice (not specific to 1
diagnosis), 2 to 8 minutes of administration time may
become relevant in patient completion percentage.
However, every practice is unique, and whether the time
difference affects practice habits should be determined
CTQ Symptom Severity Score

by the physician using the instrument. In a clinic setting,


PROMIS Pain Interference
Outcomes Measure

outcome measurement instruments synchronized with


the electronic medical record may be beneficial. The
brevity of these measurements needs to be balanced with
MHQ Pain Score

accuracy and responsiveness.


Our study has some limitations. First, only those
TABLE 2.

willing to participate in the study were included and


we do not know the number of patients who did not
wish to participate. We aim to minimize effects from

J Hand Surg Am. r Vol. -, - 2018


PROMIS COMPARED WITH MHQ AND BOSTON CTQ IN CTS 7

MHQ Pain Score TABLE 3. Time to Completion for PROMIS,


70 MHQ, and CTQ
60
Preoperative
50 Mean Time
40
to Complete
Outcomes in Seconds Standard Standard
30 Measure (95% CI) Deviation Error
20
PROMIS PF 66 (60e72) 30 3.1
10
Preoperave 1-week 6-weeks 3-months
PROMIS UE 64 (58e70) 27 2.8
Postoperave Postoperave Postoperave PROMIS PI 57 (51e63) 30 3.0
FIGURE 6: MHQ Pain Score showing a showing a continual MHQ 465 (430e500) 174 17.8
trend of decreasing pain from preoperatively through 3 months CTQ 165 (154e176) 54 5.6
postoperatively.
CI, confidence interval; CTQ, Carpal Tunnel Questionnaire; MHQ,
Michigan Hand Outcomes Questionnaire; PF, physical function; PI,
pain interference; PROMIS, Patient-Reported Outcomes
Measurement Information System; UE, upper extremity.
CTQ Symptom Severity Score
3.5
and MHQ have better responsiveness. Meanwhile, in
3
line with prior studies, we see that the MHQ appears
2.5 less responsive in capturing subtle changes in phys-
ical function initially after CTR compared with the
2
CTQ FSS.10 At the 6-week and 3-month post-
1.5 operative visits, the MHQ is more responsive than
1
PROMIS UE. With regard to pain, PROMIS PI does
Preoperave 1-week 6-weeks 3-months not capture the changes captured by the CTQ
Postoperave Postoperave Postoperave
Symptom Severity Scale or MHQ Pain Scores. For
FIGURE 7: CTQ Symptom Severity Score showing a continual CTS, PROMIS instruments are not as responsive as
trend of decreasing symptoms from preoperatively through 3 the CTQ and MHQ.
months postoperatively.

ACKNOWLEDGMENTS
this by comparing the cohort with itself, but sample We would like to thank David Mitten, MD, for
bias still exists. Our cohort may have had patients contributing by including his patients in this study,
with more severe symptoms—resulting in surgery; Allison McIntyre, MPH, CCCR, and Jamie Colap-
therefore, greater responsiveness after surgery might rete, BS, for their assistance in data collection, and
be expected. For the purposes of this study, we Chris DaSilva, BS, and the University of Rochester
limited our goals to temporal comparisons of scores Health Lab for their assistance with collection and
from the same outcome measures, qualitative com- reporting of patient-reported outcomes via UR
parisons between outcome measures, and SRM VOICE platform.
values compared with preoperative values. It should
be noted that PROMIS minimum clinically important
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