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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.
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.
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
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
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
0.17
0.34
1.17
0.60
1.8 (1.7e2.0)
Postoperative
of 0.90.
1-Week
0.21
0.68
0.06
0.43
2.6 (2.4e2.8)
Postoperative
46 (44e47)
33 (31e34)
55 (51e59)
2.3 (2.1e2.4)
Preoperative
47 (45e48)
38 (37e40)
55 (51e59)
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.
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.
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
0.49
1.07
1.62
1.8 (1.7e2.0)
Postoperative
52 (50e54)
27 (22e32)
0.02
0.48
1.02
2.3 (2.1e2.5)
Postoperative
56 (55e58)
46 (41e50)
3.1 (2.9e3.2)
Preoperative
56 (55e58)
55 (50e60)
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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