Manuscript

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Click here to access/download;Manuscript;MORH-D-2100258R1.docx

1

Japanese version of the patient-rated elbow evaluation is a useful outcome measure potentially2

assesses hand function in patients with rheumatoid arthritis who underwent total elbow

3arthroplasty

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Ryozo Haradaa, b, Keiichiro Nishidaa, Yoshiyuki Matsuyamac, Kenzo Hashizumed, Takuro Wadae,

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Yoshihisa Nasua, Ryuichi Nakaharaa, Masahiro Horitaa, Masuo Sendac, Toshifumi Ozakia

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aDepartment of Orthopaedic Surgery, Okayama University Graduate School of Medicine, Dentistry

and Pharmaceutical Sciences, Okayama, Japan10

bDepartment of Orthopaedic Surgery, Kurashiki Sweet Hospital, Okayama, Japan11

cDivision of Physical Medicine and Rehabilitation, Okayama University Hospital, Okayama, Japan12
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dDepartment of

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eDepartment of Orthopaedic Surgery, Saiseikai Otaru Hospital, Sapporo, Japan.

Rehabilitation, Japan Labour Health and Welfare Organization, Okayama Rosai
Hospital, Okayama, Japan.

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Corresponding author:

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Keiichiro Nishida, MD, PhD

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Department of Orthopaedic Surgery, Okayama University Graduate School of Medicine, Density and19

Pharmaceutical Sciences, Okayama, Japan20

2-5-1, Shikata-Cho, Kitaku, Okayama City

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E-mail: knishida@md.okayama-u.ac.jp

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TEL: +81-86-235-7273 FAX: +81-86-223-9727

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No funds or benefits were received in support of this work.

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This paper included 14 pages, five tables, and one figure.

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Keywords

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rheumatoid arthritis, total elbow arthroplasty, patient-reported outcome, patient-rated elbow

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evaluation, Mayo elbow performance score

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Abstract

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Objective

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We examined the relationship between The Japanese version of Patient-Related Elbow Evaluation

35(PREE-J) and other established subjective and objective outcome measures in Japanese patients with36

rheumatoid arthritis (RA) who underwent total elbow arthroplasty (TEA).

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Patients and Methods

38This study involved 46 elbows of 40 RA patients. We collected clinical data one year after surgery,39

including the PREE-J, the Mayo Elbow Performance Score (MEPS), Disability of the Arm, Shoulder,40

and Hand (DASH), and Hand20. The correlation and responsiveness to PREE-J were evaluated41

compared with other outcome measures pre-and postoperatively.

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Results

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Almost all outcome measures were improved significantly after surgery. Preoperative PREE-J was

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significantly correlated with preoperative DASH, Hand20, and MEPS. Interestingly, postoperative

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PREE-J did not correlate with postoperative MEPS. Multiple regression analyses revealed that46

preoperative grip strength (B = -0.09; 95% CI -0.17 to -0.01, p = 0.03) and preoperative Hand20 (B =47

0.31, 95% CI 0.03 - 0.58, p = 0.03) were significant factors those might influenced the postoperative

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PREE-J.

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Conclusions

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The PREE-J was shown to correlate well with other preoperative outcome measures among the RA

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patients included in the current study. The postoperative PREE-J after TEA was influenced by the52

preoperative grip strength and function of the hand.

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Introduction

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The elbow joint plays an important role in the reach motion of the hand to an aimed position in space,58

and the range of motion (ROM) required in daily life is reportedly 30–130°[1]. Although the elbow

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joint is not a weight-bearing joint, it is often loaded by daily activities such as standing with hands,

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lifting objects, and using a cane, and it has been reported that up to one-half of the bodyweight is61

loaded on the elbow joint during such daily activities [2].

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Rheumatoid arthritis (RA) is a chronic inflammatory disease of unknown etiology that, if not

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properly treated, leads to bone and cartilage destruction due to persistent synovitis, resulting in

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dysfunction and deformity of the joint [3]. The frequency of elbow involvement in patients with RA

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is estimated to be 20–65% [4]. Elbow joint damage caused by RA results in various degrees of66

functional impairment due to pain, limitation of the ROM, and instability. When the joint destruction67

is mild, arthroscopic synovectomy is indicated [5], but a reconstruction of the elbow joint by total

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elbow arthroplasty (TEA) is often necessary when the destruction of the joint is above Larsen grade69

III [6]. TEA has recently been recognized as a reliable procedure with good long-term results due to70

improvements in the design and materials of the prosthesis [7] [8]. Subjective evaluation of the elbow

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joint before and after TEA has been used to assess the degree of pain and activities of daily living,72

while objective evaluation has been used for ROM, stability. There are a number of publications on

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functional improvement with TEA in RA patients [9]. They mainly reported results of objective

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evaluation, implant survival, and complications, generally based on the Mayo Elbow Performance

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Score (MEPS) [10]. The MEPS is the most used physician-based, elbow-specific outcome measure

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that assesses pain, ROM, stability, and function[11]. It has been widely applied to all elbow pathology,

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including RA.

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Recently, Patient-Reported Outcome (PRO), which is a direct evaluation of the effect of treatment

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by the patient, has become more important in clinical evaluation in addition to objective evaluation by
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the physician. However, only a few studies included PROs for clinical evaluation after TEA [12]. In

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patients with RA, which is a polyarticular disorder, it is expected that even if elbow function is82

improved by TEA, it is difficult to obtain improvement in the whole function of the upper extremity.

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The DASH questionnaire is also a commonly used 30-point patient-based non-joint specific outcome

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measure designed to evaluate physical function and symptoms in patients with musculoskeletal

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disorders of the upper extremity. The ability to perform certain upper extremity activities or86difficulty and interference with daily life is rated by patients on a 5-point Likert scale [13].

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Several instruments have been used in the evaluation of elbow joint function, but PROs specific for88

the elbow joint that can be used practically, taking into account the perspectives of both patients and89

physicians, are still under development [14]. In recent years, pASES-E and Patient-Rated Elbow

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Evaluation (PREE) are mainly used [15], and PREE has been used to evaluate the function of elbows

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after injury [16], as well as those affected by RA and OA [17] and has been reported to have high92

validity and reliability [18]. Hanyu et al. previously cross-culturally adapted the PREE into Japanese

93(PREE-J) and demonstrated that the PREE-J represents a reliable, valid, and responsive instrument94

and has evaluation capacities equivalent to those of the original PREE [19].

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The primary purpose of the current study was to compare the PREE-J with other outcome measures,

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including DASH, Hand20, and MEPS, to determine the ability of PREE-J to reproducibly describe the97

elbow impairment and improvement, before and after TEA in Japanese patients with RA, respectively.

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Although preoperative PREE-J was significantly correlated with preoperative DASH, Hand20, and99

MEPS, it was revealed that postoperative PREE-J did not correlate with postoperative MEPS. As the100

distribution of the PREE-J score varied among patients postoperatively, we examined the factors that101

might influence the postoperative PREE-J

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Patients and Methods

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The current study is a single-center, retrospective, case-series study of patients with RA who

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underwent elbow arthroplasty using the JACE [20], PROSNAP [21], or Kudo [22]107

Okayama University Hospital between January 2012 and December 2016. All patients completed pre-108

and postoperative physical examination and subjective evaluation questionnaires. Patients comprised

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38 women and two men, aged 61.6 (41–80) years on average, with a mean disease duration of 23 (1–11052) years. As for disease activity, the mean preoperative DAS28-CRP was 2.93 (1.24–5.81), and111

biologic DMARDs were used in 16 patients (35%). The elbow prostheses used were JACE in 33

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elbows (72%), PROSNAP in eight elbows (17%), and Kudo in five elbows (11%) (Table 1). Informed

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consent was obtained in the form of an opt-out on the website of Okayama University Hospital. Those114

who refused entry were excluded from the analysis. The study was approved by the Ethics Committee

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of Okayama University (Approval Number: 1704-040).

elbow at116

All clinical data were evaluated at one year postoperatively because, over the long-term,

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postoperative outcomes may be affected by another surgery or a change in medication. The data

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obtained comprised grip strength and ROM as physical findings, DAS28-CRP for disease activity, and

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Health Assessment Questionnaire- Disability Index (HAQ-DI) for ADL assessment. The MEPS was

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used as an objective index, and the Japanese version of PREE (PREE-J）[19], the Japanese version of

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DASH [23], and Hand20 [24] was used for subjective evaluation were obtained and compared before

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and after surgery. In addition, we examined the correlation between the PREE-J score and MEPS,

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DASH, and Hand20. The correlations between grip strength and various scores were also examined

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before and after the surgery. To examine the preoperative factors affecting the postoperative TEA

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results, regression analysis was conducted using postoperative PREE-J as the objective variable.

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The statistical methods included a t-test for physical findings and subjective evaluation before

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and after surgery and Spearman’s rank correlation for correlation between objective indices and
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subjective evaluation. The effect size of the clinical outcomes before and after surgery was examined

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by Cohen's d. Because this study was a complete case analysis, missing value completion was not

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performed. The clinically significant variables were selected for subsequent stepwise multiple

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regression analysis. The significance level was set at p < .05, and the statistical software used was132

Easy R (EZR) [25].

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Results

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The ROM of the elbow joint was significantly increased from -34/115 degrees preoperatively to -136

25/135 degrees postoperatively (p < .01) for extension and flexion and from 58/60 degrees

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preoperatively to 77/77 degrees postoperatively (p < .01) for pronation and supination of the forearm.

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Grip strength was also significantly improved from 104 mmHg to 130 mmHg (p < .01). The MEPS

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score improved significantly from 53 points preoperatively to 98 points postoperatively (p < .01), the140

DASH score improved from 48 points preoperatively to 34 points postoperatively (p < .01), the PREE-

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J score improved from 54 points to 20 points (p < .01), and the Hand20 improved from 58 points

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preoperatively to 37 points postoperatively (p < .01). Only HAQ-DI did not show significant

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improvement. In the examination of the PREE-J subscales, the functional score improved from 25

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points preoperatively to 11 points, and the pain score improved from 29 points preoperatively to 9

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points postoperatively, indicating a greater improvement and a larger effect size. The effect of TEA

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surgery on MEPS, an objective index, was the largest at d = 3.81, followed by PREE-J at d = 1.89,

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Hand20 at d = 0.94, and DASH at d = 0.71. The effect of PREE-J was the largest in the subjective

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evaluation (Table 2).

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We examined the correlation between subjective and objective evaluations before and after

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TEA. The preoperative PREE-J showed a significant correlation with preoperative DASH, Hand20,

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and MEPS. The postoperative PREE-J also showed a significant correlation with postoperative DASH
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(r = 0.87, p < .001), Hand20 (r = 0.82, p < .001), and other subjective evaluations; however, there was153

no significant correlation with postoperative MEPS (r = -0.24, p = .11) (Table 3).

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We examined the correlation between grip strength and PREE-J, MEPS, DASH, and Hand20.

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The correlation between grip strength and the PREE-J, DASH, and Hand20 was significant before and156

after surgery. In addition, the correlation tended to be stronger in the postoperative period. However,157

there was no significant correlation between grip strength and MEPS before or after surgery (Table 4).

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As the distribution of the PREE-J score varied among patients postoperatively, we examined159

the factors that might influence the postoperative PREE-J. Although the items related to pain and usual160

activities generally improved after the surgery, it was difficult to obtain improvement in the items

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related to “Specific activities” items, such as “Pull a heavy object,” “Carry a 5kg object with my arm

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at my side”, “Throw a small object, such as a tennis ball,” and “Turn the doorknob and open a door”

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which are affected by both elbow function and hand function (Figure 1).

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Because the postoperative distribution of PREE-J was thought to be influenced by the hand

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function, multiple regression analysis with the objective variable being postoperative PREE-J was

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conducted by selecting preoperative Hand20, Grip as the explanatory variable and selecting disease167

duration and DAS28-CRP for disease activities, and preoperative MEPS for preoperative elbow

168functions. As the Variance Inflation Factor (VIF) of each item was less than 10, the regression analysis

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showed no multicollinearity. Using backward stepwise selection, preoperative Hand20

170(unstandardized coefficient: 0.31 [95% CI: 0.03 to 0.58], p = .03) and preoperative grip strength

171(unstandardized coefficient: -0.09 [95% CI: -0.17 to -0.01], p = .03), were derived as factors affecting

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postoperative outcomes (Table 5).

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Discussion

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To date, evaluation of the clinical outcome of TEA has focused on objective assessments, with less178

focus on the patient’s symptoms, functioning, and overall health status [26]. Previously, Turchin et al.

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concluded that patient-completed questionnaires should be used to assess functional outcomes after180

treatment of elbow disorders [27]. Angst et al. reported a mean postoperative DASH score of 50 points

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and a PREE score of 28 points in 79 patients (including 59 patients with RA) who underwent TEA

182[28]. Although it is not possible to make an accurate comparison of the postoperative results of TEA

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due to differences in patient characteristics and prostheses used, the results of the objective and184

subjective evaluations of the current study were comparable to those of previous reports. The current

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study first demonstrated that PREE-J shows a good correlation with other established PROs, including

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DASH and Hand20 before and after TEA in Japanese patients with RA.

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Although several instruments have been reported for the evaluation of elbow function, a report

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which examined 980 clinical studies found that MEPS was used in 82% of the elbow arthroplasties,

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DASH in 17%, and quick DASH in 7% [29]. On the other hand, there have been reports of the use of

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DASH, Oxford Elbow Score, Liverpool Elbow Score, Elbow Function Assessment, PREE, etc., for

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PRO of elbow function [30], of which DASH is the most commonly used. DASH has the property of192

recording a poor response to treatment when the effect of the intervention is less than that of the entire

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upper limb [30]. It should also be noted that DASH reflects the function of bilateral upper extremities,

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and the score might be affected by contralateral upper extremity dysfunction in patients with RA. It

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has also been reported that DASH is more likely to reflect shoulder joint function and less likely to

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reflect elbow joint dysfunction [18]. In a study using effect size to evaluate the response of various

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PROs in the postoperative results of TEA, it was reported that the effect size of DASH was smaller

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than that of PREE and that the ability to evaluate the effect of treatment was lower [18]. Following

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these studies, our result also showed that the effect size was 1.89 for PREE-J and 0.71 for DASH.
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In the treatment of upper limb fractures, it has been reported that the correlation between

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improvement in joint function and PRO becomes stronger with time [31]. It has been reported that202

three PROs (SPADI, ASES, SST) correlate better postoperatively than preoperatively in shoulder

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surgery [32]. While the DASH is designed to assess overall upper limb function, the Hand20

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specifically hand function, and the PREE specifically elbow function, these measures share similar

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items. Therefore, it is expected that the correlation between each score will increase as the number of206

impaired joints decreases, and it is thought that the correlation between PREE, DASH, and Hand20

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increased as elbow function improved with TEA.

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In the present study of RA patients with polyarticular disorders, MEPS and PREE-J correlated

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well when the elbow joint was impaired preoperatively. TEA significantly improved both MEPS and210

PREE-J, but the degree of improvement in PREE-J was less than in MEPS. One reason for this could

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be the ceiling effect of MEPS. In addition, the functional assessment items of MEPS do not place a212weight on the assessment of hand dysfunction after TEA. The PREE-J, which has detailed questions

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about upper limb function, may correctly assess difficult functions to improve with TEA.

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Analysis of PROs is often limited to the examination of the total score of secondary items, and215

there are few reports on the examination of individual items. Each component of PREE-J can be216

roughly classified into “pain” and “function.” In the present study, pain and daily activities improved

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uniformly, but the degree of improvement varied for specific activities, suggesting that there were218

items that were unlikely to improve as a result of TEA despite the patients’ expectations. While the219

MEPS functional assessment is mainly related to the elbow, each item of the PREE-J is a good220

representation of elbow joint function, hand dexterity impairment, and upper limb muscle strength.

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Therefore, we hypothesized that the lack of improvement in PREE might be due to the residual

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dysfunction of the hand.

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Our current analysis showed that preoperative Hand20 and grip strength were significant factors

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that might influence the relatively wide distribution of postoperative PREE-J. Hand20 is a subjective

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assessment of upper limb function that includes many items related to the fingers and is superior to226

other upper limb PROs in assessing hand function. The Hand20 is widely used in Japan for the227

evaluation of degenerative diseases related to the hand, in addition to fracture treatment [33] [34].

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In addition, grip strength has a great influence on upper limb function and is reportedly an important229

key factor for upper limb function in RA patients as well [35].

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strong correlation with PREE-J, DASH, and Hand20, but no correlation with MEPS (Table 4). These

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results also explain why the correlation of PREE-J and MEPS decreased after the operation while

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PREE and DASH or Hand20 show a good correlation. Cusick et al. examined the accuracy and233

reliability of MEPS and described that a potential weakness of the MEPS compared with other systems

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are that it does not include strength or deformity calculation in the overall score, but excluding these235

factors allows the MEPS to be completely patient-derived, which can be viewed as an advantage[36].

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By assessing grip strength preoperatively, it may be possible to share information with patients237

preoperatively about the prediction of postoperative outcomes and functions to be improved. Future238

studies may include the development of the novel objective outcome measure that includes the239

assessment of grip strength.

Grip strength showed a relatively

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There were some limitations to this study. First, we did not assess depression or mental status

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in pain-related PRO assessments. In many cases, the assessment of pain and ADL is greatly influenced242

by the patient's environment, experiences, and emotions. Second, individual patients may have243

different criteria for pain assessment, which may have affected the results of both subjective and244

objective evaluations. Third, changes in disease activity in RA may affect ADL indices, but we failed245

to capture changes in disease activity one year after surgery. Although DAS28-CRP was improved

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between the preoperative and final survey assessments, we were not able to assess changes in function
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other than at the surgical site or the degree of progression of joint destruction. However, in the present

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study, clinical data were surveyed at one year after surgery, and thus the effect of changes in disease249

activity was considered to be small.

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Lastly, we evaluated the hand functions as the important adjacent joint disorder, but the effect of251

shoulder joint disorder was not considered in the current study. In our institute, shoulder surgery

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usually preceded elbow surgery in cases with multiple joint disorders. Therefore, cases with severe253

shoulder dysfunction were not included in this study. The mean shoulder joint range of motion was254

144±33 (80-170) degrees in flexion and 139±46 (60-170) degrees in abduction. The impact of the255

shoulder joint is thought to be relatively small in this case series, but further study is needed to clarify

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the correlation between shoulder and elbow function after TEA.

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In conclusion, preoperative PREE-J significantly correlated with preoperative DASH, Hand20,

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and MEPS, and postoperative DASH and Hand20 in Japanese patients with RA who underwent TEA.

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The effect size of PREE-J was larger than that of DASH and Hand20. The standard deviation of pre-260

and postoperative PREE-J was similar, suggesting a relatively wide distribution of PREE-J, partly

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reflecting the hand function, which was not improved by TEA. Our results suggested the importance262

of evaluation by PRO in addition to objective evaluation to share the information for benefits and263

limitations obtained by TEA and to increase the postoperative satisfaction of RA patients.

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Conflict of interest

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None

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References

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Replay to Reviewer 2

Click here to access/download;Authors' Response to
Reviewers' Comments;MORH-D-21-

Response to Reviewer #2:
Thank you very much for your useful comments on our manuscript. We carefully considered yourcomments. In revising the manuscript, we have addressed all comments, and have made substantialchanges in response to all issues raised in the review.

1,

The title and their study design are elusive. If they tried to examine the discordance

between subjective and objective assessment, then they should focus on this point. However, theiranalysis and the way of writing seem obscure and miss the point. Or did they try to investigate
the predictors of postoperative PREE after TEA and find the discordance accidentally?
Reply: We thank you for the Reviewer’s question.
Initially, we aimed to determine whether the PREE-J correlated with existing assessment methods
before and after TEA surgery in RA patients. As you pointed out, it was found that PREE-J and MEPS
lost their correlation postoperatively, and we analyzed the factors behind this. We have changed thetitle to “Japanese version of the patient-rated elbow evaluation is a useful outcome measure potentiallyassesses hand function in patients with rheumatoid arthritis who underwent total elbow arthroplasty.”

We added the following sentences to the end of the Introduction and rewrote the Abstract andIntroduction according to the title change. Revised sentences were written in red and underlined.
(page4, line 92~)
Hanyu et al. previously cross-culturally adapted the PREE into Japanese (PREE-J) and demonstrated
that the PREE-J represents a reliable, valid, and responsive instrument and has evaluation capacities
equivalent to those of the original PREE [19].
The primary purpose of the current study was to compare the PREE-J with other outcome measures,
including DASH, Hand20, and MEPS, to determine the ability of PREE-J to reproducibly describe theelbow impairment and improvement, before and after TEA in Japanese patients with RA, respectively.
Although preoperative PREE-J was significantly correlated with preoperative DASH, Hand20, and
MEPS, it was revealed that postoperative PREE-J did not correlate with postoperative MEPS. As the
distribution of the PREE-J score varied among patients postoperatively, we examined the factors thatmight influence the postoperative PREE-J.

2,

One of the unique results of this study was the correlation of PREE and MEPS was

decreased after operation while the correlations of PREE and DASH or Hand20 were increased.
Why? Please add some analytical results to this point.

Reply: We appreciate the reviewer’s insightful suggestion. In this study, TEA improved elbow function
by providing good pain relief, functional range of motion, and joint stability. As a result of achieving
all MEPS scoring items reasonably well postoperatively, the scores were concentrated in the higher
range. This may be a result of the ceiling effect of MEPS. The postoperative MEPS in this paper was
97.7+1SD(3.6)=101.3, which exceeded the upper limit of the MEPS score of 100. On the other hand,
it is thought that the functional evaluation items of MEPS could not fully evaluate the functional
impairment of the hand that was not improved by TEA; it is thought that the items that could not be
improved by TEA remained in PREE-J, which has more detailed questions about upper limb function
than MEPS.

Next, about improving the postoperative score correlations of PREE, DASH, and Hand20, there is areport (Rowan J Michael, et al., JSES, 2019.) that the correlations of the three PROs (SPADI, ASES,
SST) improved postoperatively in shoulder surgery.
Although the DASH is designed to assess overall upper limb function, the Hand20, specifically handfunction, and the PREE specifically elbow function, these measures share similar items. Therefore,
the fewer impaired joints, the better the correlation between the respective scores should be.

We have also made the following corrections in the “Discussion.”(page9, Line200 ~)In the treatment of upper limb fractures, it has been reported that the correlation between
improvement in joint function and PRO becomes stronger with time [31]. It has been reported thatthree PROs (SPADI, ASES, SST) correlate better postoperatively than preoperatively in shoulder
surgery [32]. While the DASH is designed to assess overall upper limb function, the Hand20
specifically hand function, and the PREE specifically elbow function, these measures share similar
items. Therefore, it is expected that the correlation between each score will increase as the number of
impaired joints decreases, and it is thought that the correlation between PREE, DASH, and Hand20
increased as elbow function improved with TEA.

In the present study of RA patients with polyarticular disorders, MEPS and PREE-J correlated wellwhen the elbow joint was impaired preoperatively. TEA significantly improved both MEPS and
PREE-J, but the degree of improvement in PREE-J was less than in MEPS. One reason for this could
be the ceiling effect of MEPS. In addition, the functional assessment items of MEPS do not place aweight on the assessment of hand dysfunction after TEA. The PREE-J, which has detailed questions
about upper limb function, may correctly assess difficult functions to improve with TEA.

3,

They show that preoperative grip strength was an independent predictor for postoperative

PREE. Is the preoperative and postoperative grip strength significantly correlated withpreoperative and postoperative PREE, respectively?
Reply: We appreciate the reviewer’s insightful suggestion. As you pointed out, the new analysis
showed a correlation between grip strength and PREE-J before and after surgery. This result is very
interesting, and when we examined DASH and Hand20, we found a strong correlation in bothmeasures, but MEPS does not correlate with grip strength. These results were added to the Method,
Results, and Discussion section and summarized in Table 4. These results also explain why thecorrelation of PREE-J and MEPS decreased after the operation while PREE-J and DASH or Hand20
show a good correlation, which you raised in comment #2.

If so, does the addition of pre-and post-operative grip strength to MEPS increase the correlation
with respective PREE?

Reply: Thank you for your comment. At the moment, no report can discuss adding other elements toMEPS for analysis. The MEPS score is weighted for pain, range of motion, stability, and function.
When grip strength is added, a new weighting is required, making reliable and reproducible scoring
difficult within the scope of this study. Cusick et al. examined the accuracy and reliability of MEPS
and stated the following: “A potential weakness of the MEPS compared with other systems is that it
does not include strength or deformity calculation in the overall score, but excluding these factors
allows the MEPS to be completely patient-derived, which can be viewed as an advantage.” We add tothe discussion about your interesting idea for the development of a novel assessment tool.

We have made the following corrections in the “Patients and Methods.”(page5. Line122 ~):In addition, we examined the correlation between the PREE score and MEPS, DASH, and Hand20.
The correlations between grip strength and various scores were also examined before and after thesurgery.

We have also made the following corrections in the “Results.”(page6, Line149~)
We examined the correlation between subjective and objective evaluations before and after TEA. The
preoperative PREE showed a significant correlation with preoperative DASH, Hand20, and MEPS.
The postoperative PREE-J also showed a significant correlation with postoperative DASH (r = 0.87,
p < .001), Hand20 (r = 0.82 p < .001), and other subjective evaluations; however, there was no
significant correlation with postoperative MEPS (r = -0.24, p = .11) (Table 3).
We examined the correlation between grip strength and PREE-J, MEPS, DASH, and Hand20. The
correlation between grip strength and the PREE-J, DASH, and Hand20 was significant before andafter surgery. In addition, the correlation tended to be stronger in the postoperative period. However,there was no significant correlation between grip strength and MEPS before or after surgery (Table 4).

We have also made the following corrections in the “Discussion.”(page10, line226~)
The Hand20 is widely used in Japan for the evaluation of degenerative diseases related to the hand, in
addition to fracture treatment [33] [34].
In addition, grip strength has a great influence on upper limb function and is reportedly an important

key factor for upper limb function in RA patients as well [35]. Grip strength showed a relatively
strong correlation with PREE-J, DASH, and Hand20, but no correlation with MEPS (Table 4). These
results also explain why the correlation of PREE-J and MEPS decreased after the operation while
PREE and DASH or Hand20 show a good correlation. Cusick et al. examined the accuracy andreliability of MEPS and described that a potential weakness of the MEPS compared with other systems
are that it does not include strength or deformity calculation in the overall score, but excluding thesefactors allows the MEPS to be completely patient-derived, which can be viewed as an advantage[36].
By assessing grip strength preoperatively, it may be possible to share information with patients
preoperatively about the prediction of postoperative outcomes and functions to be improved. Futurestudies may include the development of the novel objective outcome measure that includes theassessment of grip strength.

4,They showed that the improvement of several items in PREE were hard to achieve. If theyargue that this is one of the reasons of the discordance, does the deletion of such items frompostoperative PREE increase the correlation with postoperative MEPS?

Reply: Thank you for your question. We tried deleting some of the items in the PREE, but there wasno significant change in the correlation with postoperative MEPS. One possible explanation was theceiling effect of MEPS. The other reason was that most PREE items reflect both hand and elbow
function, so deleting certain items did not change the correlation.
The items composed of PREE-J reflect the reach function of the elbow, as well as hand function
and strength. We thought that the remaining hand dysfunction might be the cause of the limitation in
improving the PREE after TEA, and our further analysis focused on the hand function.

We have made the following corrections in the “Results.”(page7, line158~)

As the distribution of the PREE-J score varied among patients postoperatively, we examined thefactors that might influence the postoperative PREE-J. Although the items related to pain and usual
activities generally improved after the surgery, it was difficult to obtain improvement in the items
related to “Specific activities” items, such as “Pull a heavy object,” “Carry a 5kg object with my arm
at my side,” “Throw a small object, such as a tennis ball,” and “Turn the doorknob and open a door”

which are affected by both elbow function and hand function (Figure 1).

We have also made the following corrections in the “Discussion.”(page9, line214~)
Analysis of PROs is often limited to the examination of the total score of secondary items, and there
are few reports on the examination of individual items. Each component of PREE-J can be roughlyclassified into “pain” and “function.” In the present study, pain and daily activities improved uniformly,
but the degree of improvement varied for specific activities, suggesting that there were items that wereunlikely to improve as a result of TEA despite the patients’ expectations. While the MEPS functional
assessment is mainly related to the elbow, each item of the PREE-J is a good representation of elbow
joint function, hand dexterity impairment, and upper limb muscle strength. Therefore, wehypothesized that the lack of improvement in PREE might be due to the residual dysfunction of thehand.

We thank all the reviewers for their constructive comments. We believe our revised manuscript isgreatly strengthened as a result of the major revisions we have made. We hope you agree with us andthat you find the paper acceptable for publication in Modern Rheumatology.
We look forward to hearing from you.

Replay to Reviewer 3

Click here to access/download;Authors' Response to
Reviewers' Comments;MORH-D-21-

Response to Reviewer #3:
Thank you very much for your useful comments on our manuscript. We carefully considered yourcomments. In revising the manuscript, we have addressed all comments and have made substantialchanges in response to all issues raised in the review.

1)

Page 6, line 16~23: In RA patients with multiple-joint disorders, the effects of the shoulder

joint cannot be overlooked. Questionnaires about the function in PREE also include content
related to the condition of the shoulder joint. MEPS also has items of function, but it seems tohave a lighter weight than PREE. Please comment on why the shoulder evaluation was missed,
even though hand evaluation was included.
The improvement of PREE after TEA might greatly affected by the preoperative function of theshoulder as well as the hand.

Reply: We appreciate this comment by the Reviewer.
The function component of MEPS is also affected by shoulder and hand function. As the reviewer
suggested, the weight of each joint should be different in each score. In our institute, shoulder surgery
is usually preceded by elbow surgery in cases with multiple joint disorders. So, in our case series,
patients who underwent TEA didn’t have severe shoulder disfunction. Their range of shoulder motion
was 144±33(80-170) degrees in flexion and 139±46 (60-170) degrees in abduction. Nevertheless,shoulder function possibly affects the PREE, so we added the limitation as follows.

We added the following sentences in the “Discussion.”(page11, Line250 ~)Lastly, we evaluated the hand functions as the important adjacent joint disorder, but the effect ofshoulder joint disorder was not considered in the current study. In our institute, shoulder surgery
usually preceded elbow surgery in cases with multiple joint disorders. Therefore, cases with severe
shoulder dysfunction were not included in this study. The mean shoulder joint range of motion was
144±33 (80-170) degrees in flexion and 139±46 (60-170) degrees in abduction. The impact of theshoulder joint is thought to be relatively small in this case series, but further study is needed to clarify
the correlation of shoulder and elbow function after TEA.

2) Page 7, line1~4: Please indicate what is the objective variable.

As the reviewer detected, the dependent variable was not explained in the first version. We revised the
explanation of variables used for multi regression analysis to specify that the PREE score was thedependent variable.

(page7, line164~)
Because the postoperative distribution of PREE-J was thought to be influenced by the hand function,
multiple regression analysis with the objective variable being postoperative PREE-J was conductedby selecting preoperative Hand20, Grip as the explanatory variable and selecting disease duration and
DAS28-CRP for disease activities, and preoperative MEPS for preoperative elbow functions.

3) Page 7, line23: provably→probably

We apologize for the typography.
As a result of the response to other reviewer comments, the relevant sentences were deleted in therevised version.

(Page 7, line23, )In general, physical function and pain are usually evaluated in clinical studies [25], while indicatorsthat patients expect to improve have not been well recognized [26], thus probably causing
discrepancies between physician and patient evaluations [27].

→（This sentence has been deleted in the revised version.）

We thank all the reviewers for their constructive comments. We believe our revised manuscript isgreatly strengthened as a result of the major revisions we have made. We hope you agree with us andthat you find the paper acceptable for publication in Modern Rheumatology.
We look forward to hearing from you.

Table 1-5

Table 1. Patient’s baseline characteristic.*
Variable
Female / Male

Total 46 elbows/40 patients
38 / 2Age at surgery, years

61.6 ± 10.1 (41 ~ 80)

Disease duration, years

23.0 ± 14.5 (1.0 ~ 52)

DAS28-CRP

2.93 ± 1.0

Use of biologic agents, no. (%)

16 (35)

Elbow implant, no. (%)
JACE2033(72)

PROSNAP21

8(17)

Kudo22

5(11)*Values are mean ± SD unless indicated otherwise.

Table 2. Pre- and postoperative range of motion of elbow and forearm, grip strength, andmeasurement＊
Characteristic

Preoperative

Postoperative

p Value

Effect size

Elbow flexion, degree

115 ± 19135 ± 9< .001- extension-34 ± 22-25 ± 16.005

- total arc

80 ± 34

110 ± 19< .001

Forearm supination

58 ± 2977 ± 16.003- pronation

60 ± 2577 ± 16.006- total arc

116 ± 47

154 ± 27

< .001

Grip Strength, mmHg

104 ± 67130 ± 75

.007

DASH

48.2 ± 18.9

33.7 ± 21.9

< .001

0.71

Hand2058.3 ± 19.7

36.6 ± 26.5

< .001

0.94

PREE-J total

54.1 ± 18.1

19.9 ± 18.1

< .001

1.89- PAIN28.8 ± 11.1

9.1 ± 9.8

< .001

1.88- FUNCTION

25.3 ± 11.3

10.8 ± 10.4

< .001

1.33- Specific activities

55.4 ± 24.8

23.7 ± 23.2

< .001

1.32- Usual activities

20.5 ± 11.3

8.7 ± 9.6

< .001

1.13

HAQ-DI

1.01 ± 0.65

0.99 ± 0.81

.994

0.03

MEPS

52.7 ± 16.3

97.7 ± 3.6< .001

3.81*Values are mean ± SD unless indicated otherwise.
DASH: The Disabilities of the Arm, Shoulder and Hand score; Hand20: illustrated questionnaire,comprising 20 short questions to assess disorders of the upper limb; PREE-J: The Japanese Version ofPatient-Rated Elbow Evaluation; HAQ-DI: The Health Assessment Questionnaire Disability Index;
MEPS: Mayo Elbow Performance Score.

Table 3. Spearman’s correlation coefficients for pre-and postoperative PREE-J score*
Questionnaire

Preoperative

p Value

Correlation estimate

Postoperative

p Value

Correlation estimate

DASH

0.48

< .01

0.87

< .01

Hand20

0.54

< .01

0.82

< .01

MEPS

- 0.38

< .01

-0.24

.11

PREE-J: The Japanese Version of Patient-Rated Elbow Evaluation; DASH: The Disabilities of theArm, Shoulder and Hand score; Hand20: illustrated questionnaire, comprising 20 short questions toassess disorders of the upper limb; MEPS: Mayo Elbow Performance Score.

Table 4. Spearman’s correlation coefficients for pre-and postoperative grip strength*
Questionnaire

Preoperative Correlation

p Valueestimate

Postoperative

p Value

Correlation estimate

PREE-J

-0.30

.04

-0.69

< .01

DASH

-0.55

< .01

-0.75

< .01

Hand20

-0.61

< .01

-0.80

< .01

MEPS

0.21

.17

0.15

.33

PREE-J: The Japanese Version of Patient-Rated Elbow Evaluation; DASH: The Disabilities of theArm, Shoulder and Hand score; Hand20: illustrated questionnaire, comprising 20 short questions toassess disorders of the upper limb; MEPS: Mayo Elbow Performance Score.

Table 5. Associations of Postoperative PREE-J score with clinical features by multiple regression
analysis
UnstandardizedStandardized

coefficient

coefficient

B

SE(Intercept)

11.3

10.8

Grip Strength

-0.09

0.04

Hand20

0.31

0.14

β

p Value

95%CI

Adjusted R2.30-10.5 to 33.1

0.28

-0.32

.03

-0.17 to -0.01

0.33

.03

0.03 to 0.58

PREE-J: The Japanese Version of Patient-Rated Elbow Evaluation; Hand20: illustrated questionnaire,comprising 20 short questions to assess disorders of the upper limb.

Figure 1

Click here to access/download;Figure;Figure1.png