http://informahealthcare.com/mor ISSN 1439-7595 (print), 1439-7609 (online) Mod Rheumatol, 2015; 25(2): 241–245 © 2014 Japan College of Rheumatology DOI: 10.3109/14397595.2014.939420

ORIGINAL ARTICLE

Construct validity, reliability, response rate, and association with disease activity of the quick disabilities of the arm, shoulder and hand questionnaire in the assessment of rheumatoid arthritis Kensuke Ochi1,3*, Takuji Iwamoto1,3*, Asami Saito1*, Katsunori Ikari1, Yoshiaki Toyama3, Atsuo Taniguchi2, Hisashi Yamanaka2, and Shigeki Momohara1 1Department of Orthopaedic Surgery, Institute of Rheumatology, Tokyo Women’s Medical University, Shinjuku, Tokyo, Japan, 2Department of Rheumatology, Institute of Rheumatology, Tokyo Women’s Medical University, Shinjuku, Tokyo, Japan,

and 3Department of Orthopaedic Surgery, School of Medicine, Keio University, Shinjuku, Tokyo, Japan Abstract

Keywords

Objective. First objective is to validate the Disabilities of the Arm, Shoulder and Hand (DASH) and Quick DASH (QuickDASH) questionnaire in rheumatoid arthritis (RA) patients with functional upper extremity impairment. Next is to clarify which clinical factor is associating with QuickDASH using a large cohort of RA. Methods. The QuickDASH and DASH were applied to our 94 RA patients who underwent surgery for functional upper extremity impairment. Next, the QuickDASH was applied to our cohort of 5191 Japanese patients with RA. Results. In the first cohort of 94 RA patients, both QuickDASH and DASH displayed excellent reliability and validity. The response rate of patients ⬍ 65 and ⱖ 65 years of age showed significant difference in the DASH but not in the QuickDASH. In the second cohort with 5191 RA patients, QuickDASH showed a high response rate (93%) and good to moderate correlation with Japanese version of the Health Assessment Questionnaire (r ⫽ 0.88) and disease activity score of 28 (DAS28, r ⫽ 0.53). Change in QuickDASH score and DAS28-based European League Against Rheumatism response showed significant correlation. Conclusion. QuickDASH seems suitable for evaluating upper extremity impairment, disability index, and disease control in a large cohort of RA patients including elderly patients.

Disabilities of the arm, shoulder and hand; Functional impairment; Health Assessment Questionnaire; Quick disabilities of the arm, shoulder and hand; Rheumatoid arthritis

Introduction Despite recent advancements in treatment [1], rheumatoid arthritis (RA) remains a chronic and progressive disease, and preventing functional impairment is one of the major focuses in its treatment [2–7]. Therefore, continuous longitudinal evaluation of functional impairment is necessary for assessing patient’s quality of life, disease activity, disease control, and treatment outcome [4,8–12]. Health measurement scales are important tools to evaluate health status and determine the outcome of medical interventions. The self-administered Stanford Health Assessment Questionnaire (HAQ) has been established as a reliable instrument and translated in numerous languages for the assessment of physical impairment in patients with RA [8]. However, as the HAQ is composed of eight items, it has been suggested that this questionnaire may be a good tool for assessing total functional disability, but it may not be a good tool for assessing local functional disabilities such as upper or lower extremity impairment *These authors equally contributed to this work. Correspondence to: Kensuke Ochi, MD, PhD, Department of Orthopaedic Surgery, Institute of Rheumatology, Tokyo Women’s Medical University, 10-22 Kawada-cyo, Shinjuku-ku, Tokyo 162-0054, Japan. Current address: Department of Orthopaedic Surgery, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan. Tel: ⫹ 81-3-5269-1725. Fax: ⫹ 81-3-5269-1726. E-mail: ochi@1998. jukuin.keio.ac.jp

History Received 18 February 2014 Accepted 25 June 2014 Published online 31 July 2014

[3,10–13]. We also demonstrated that the Japanese version of the HAQ (J-HAQ) score [9] did not change in our patients with RA who underwent surgical procedures for upper and lower extremity impairment, suggesting that the functional impairment of these extremities may better be assessed by using extremity-specific tools other than J-HAQ [4]. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was devised as a region-specific measurement by the American Academy of Orthopaedic Surgeons (AAOS) in 1996 [14], and it is now available in several languages and countries, including Japan (DASH-JSSH) [10,15]. Previous studies revealed that the DASH is a reliable and valid questionnaire for measuring impairment of the upper extremities in patients with RA [10–12]. These studies also indicated that DASH correlates with the disease activity of RA represented by disease activity score 28 (DAS28). However, because DASH consists of 30 items, the elderly individuals and patients with physical impairment have difficulty completing this full form, resulting in rather low response rates [16–19]. Considering that a high response rate is essential for evaluating cohort studies [2,20], DASH may not be suitable for large RA cohort studies that include elderly or physically impaired individuals [16]. The Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH) was developed as a shortened version of DASH. It uses 11 of the original 30 items to measure physical function and symptoms in people with any or multiple musculo-

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skeletal disorders of the upper extremities and is now available in several languages, including Japanese (QuickDASH), after studies verified its reliability and validity [15,16,19]. Although it has been suggested that QuickDASH-JSSH has an advantage over DASH-JSSH for large cohort studies that include elderly patients [16], however, to the best of our knowledge, there is no study validating whether QuickDASH is a reliable and valid questionnaire for measuring upper extremity function in a large cohort of patients with RA. In this study, we first hypothesised that QuickDASH could be a more valuable tool for evaluating upper extremity impairment than DASH in a cohort of RA patients with upper extremity impairment. We also hypothesised that the correlation between function of the upper extremity and disease activity/disease control of RA may be confirmed in a large cohort of patients with RA by using QuickDASH. Based on these ideas, we first compared DASHJSSH and QuickDASH-JSSH in our 94 Japanese patients with RA who underwent upper extremity surgery to treat upper extremity impairment (cohort of upper extremity impairment; Table 1). Next, we applied QuickDASH-JSSH in our large observational cohort study of Japanese patients with RA (Institute of Rheumatology Rheumatoid Arthritis [IORRA]; Table 1) and analysed its correlations with the disease activity parameters and disease control parameters proposed by the European League Against Rheumatism (EULAR) [21].

Methods Self-administered questionnaires The disability of Japanese patients with RA was measured with the J-HAQ [9]. The HAQ is a self-administered questionnaire with eight categories of function, including dressing, rising, eating, walking, hygiene, reach, grip, and daily activities. The DASHJSSH is a self-administered, upper extremity-specific questionnaire consisting of 30 questions, including 21 physical function items, 6 symptom items, and 3 social role/function items [15].

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QuickDASH-JSSH is a shorter version of DASH-JSSH in which 11 items are extracted from DASH-JSSH [16]. It consists of six physical function items, three symptom items, and two social role/ function items. In both DASH-JSSH and QuickDASH-JSSH, each question consists of a 5-point Likert scale. Therefore, the total score ranges from 30 (best function) to 150 (worst function) in DASH-JSSH and from 11 (best function) to 55 (worst function) in the QuickDASH-JSSH. To simplify the results, the scores for both questionnaires were divided by the number of responses, subtracted by 1, and finally multiplied by 25. As a result, the best possible score was 0 and the worst possible score was 100. DASH-JSSH and QuickDASH-JSSH evaluation in 94 patients with RA with upper extremity impairment We examined the correlation between DASH-JSSH and QuickDASH-JSSH in 94 patients with RA (9 males, 85 females; mean age, 55 years; age range, 20–79 years) who had undergone surgical procedures to correct upper extremity impairment (upper extremity impairment cohort; Table 1). Both questionnaires were examined 6 months after the surgery. Surgical procedures were performed on the fingers in 48 patients, the wrist in 24 patients, the elbow in 17 patients, and the shoulder in 4 patients. The reliability and intra-class correlations of DASH-JSSH and QuickDASH-JSSH were also examined in 17 of the 94 patients who responded to both questionnaires over an interval of 7 days. Reliability was analysed with Cronbach’s alpha coefficient, and the intra-class correlation was analysed with a test–retest method. The correlation between DASH-JSSH and QuickDASH-JSSH scores was analysed with Pearson’s product moment correlation coefficient. Patients’ written consent was obtained according to the Declaration of Helsinki, and this study was approved by the IRB of our institute. IORRA cohort The IORRA cohort was established in October 2000 as a single institution-based, large observational cohort of Japanese patients

Table 1. Demographics, clinical variables, and medication in our two cohorts. Parameters Number of patients Demographic variables Age, years Women, % BMI, kg/m2 Clinical variables RA disease duration, years DAS 28 J-HAQ score, 0–3 DASH-JSSH, 0–100 Quick DASH-JSSH, 0–100 Patient pain VAS, 0–10 cm Patient global VAS, 0–10 cm Physician global VAS, 0–10 cm Serum CRP, mg/100 mL ESR, mm/h RF (IU/mL) Medications Disease modifying anti-rheumatic drug use, % Corticosteroid use, % Daily prednisolone dose, mg/day MTX use, % Weekly MTX dose, mg/week Biologic use, %

Cohort of upper extremity impairment 94

IORRA cohort 5191

56.4 (13.0) 89.6 20.1 (2.6)

59.6 (13.0) 84.4 21.3 (3.1)

16.5 (10.1) 3.4 (0.8) 1.16 (0.8) 40.8 (22.2) 36.2 (21.0) 3.7 (2.8) 3.6 (2.6) 1.6 (1.0) 0.51 (0.9) 29.5 (19.1) 81.1 (103.8)

13.2 (9.4) 3.25 (1.1) 0.71 (0.76) NA 19.9 (19.7) 2.7 (2.5) 2.8 (2.4) 1.5 (1.5) 0.70 (1.3) 31.8 (23.0) 126.2 (272.8)

85.1 71.6 4.6 (2.0) 80.6 9.0 (3.0) 6.0

90.5 48.4 4.2 (2.7) 66.6 7.9 (3.2) 6.9

RA rheumatoid arthritis, BMI body mass index, DAS Disease Activity Score, J-HAQ Japanese version of Health Assessment Questionnaire, DASH Disabilities of the Arm, Shoulder and Hand, JSSH the Japanese Society for Surgery of the Hand, QuickDASH Quick Disabilities of the Arm, Shoulder and Hand, VAS visual analogue scale, CRP C-reactive protein, ESR erythrocyte sedimentation rate, RF rheumatoid factor, MTX methotrexate

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with RA recruited by our institute [2,20]. All participants were diagnosed with RA according to the 1987 classification criteria for RA of the American College of Rheumatology [22] and surveyed biannually. In principle, we enrolled all the patients who had visited our institution in this IORRA cohort; only 2% refused to enrol. Approximately 5000 patients were involved in each phase of the survey, and ⬎ 98% submitted completed questionnaires by mail. Therefore, patient selection bias, if any, is likely small. In this study, we analysed 5191 patients who participated in the IORRA survey in both October 2008 and October 2009 (Table 1). We estimate that the patients in the IORRA cohort represent ⬎ 1% of all Japanese patients with RA, as the number of patients with RA in Japan has been estimated to be ⬎ 700,000 [2]. Based on this cohort, more than 70 publications have described various characteristics of Japanese patients with RA, including disease activity, fracture, falls, arthroplasty, and mortality [2–4,20,23–40].

Figure 1. Correlation between DASH-JSSH and QuickDASH-JSSH in our upper extremity impairment cohort.

Evaluation of QuickDASH-JSSH in 5191 patients with RA by using the IORRA cohort

Evaluation of QuickDASH-JSSH in the IORRA cohort

The correlations of QuickDASH-JSSH with disease duration, serum C-reactive protein (CRP) levels, the erythrocyte sedimentation rate (ESR), J-HAQ, visual analogue scale (VAS) for pain, and DAS28 in October 2008 were analysed with Pearson’s correlation analysis. Next, changes in QuickDASH-JSSH scores between these two time points were defined as follows: ΔQuickDASHJSSH (ΔQuickDASH-JSSH ⫽ [QuickDASH-JSSH score of October 2009] ⫺ [QuickDASH-JSSH score of October 2008]). The correlation between ΔQuickDASH-JSSH and the DAS28based European League Against Rheumatism (EULAR) response [21] was analysed by using the Mann–Whitney U test and analysis of variance.

Among the 5191 patients who participated in the IORRA cohort study in October 2008 (Table 1), 4946 patients (95.3%) responded to QuickDASH-JSSH. High correlation was observed between QuickDASH-JSSH and J-HAQ (r ⫽ 0.88). Next, we analysed the correlations of QuickDASH-JSSH with DAS28, VAS for pain, serum CRP levels, and ESR, as well as correlations between J-HAQ and the same factors (Table 3). QuickDASH-JSSH had stronger correlations with DAS28 and VAS for pain than J-HAQ (Table 3). The correlation between QuickDASH-JSSH and DAS28 according to disease duration also was analysed. The correlation between these two factors was higher in patients whose disease duration was ⬍ 5 years (r ⫽ 0.61) than in patients whose disease duration was ⱖ 15 years (r ⫽ 0.49).

Results DASH-JSSH and QuickDASH-JSSH in the upper extremity impairment cohort Among the 94 patients with RA in the upper extremity impairment cohort (Table 1), 79 responded to DASH-JSSH (84%; mean score, 40.9 [SD, 22.2]) and 85 responded to QuickDASH-JSSH (90.4%; mean score, 36.3 [SD, 21]) (Table 2). Seventy-seven patients (81.9%) responded to both questionnaires. The response rates for DASH-JSSH were 91% (61/67) for patients ⬍ 65 years of age and 66.7% (18/27) among patients ⱖ 65 years of age; this difference was significant (P ⫽ 0.01). However, the response rates for QuickDASH-JSSH was 94% (63/67) among patients ⬍ 65 years of age and 81.5% (22/27) among those ⱖ 65 years of age, with no significant difference. Cronbach’s alpha coefficient was 0.98 for DASH-JSSH and 0.91 for QuickDASHJSSH, whereas the intra-class correlation coefficient was 0.96 for DASH-JSSH and 0.95 for QuickDASH-JSSH. High correlation was noted between DASH-JSSH and QuickDASH-JSSH (r ⫽ 0.97) (Figure 1).

Table 2. Comparison of DASH-JSSH and QuickDASH-JSSH scores in our cohort of patients with upper extremity impairment. Cronbach’s alpha coefficient Intra-class correlation Response rate (all age), % ⬍ 65 years old ⱖ 65 years old

DASH-JSSH 0.98

QuickDASH-JSSH 0.91

0.96 81.7 91.0 66.7

0.95 90.3 94.0 81.5

DASH-JSSH Disabilities of the Arm, Shoulder and Hand, QuickDASH Quick Disabilities of the Arm, Shoulder and Hand

Correlation between changes in the QuickDASH-JSSH score and DAS28-based EULAR response in the IORRA cohort Among the 4946 participants who completed QuickDASH-JSSH in October 2008, 4098 participants completed QuickDASH-JSSH in October 2009, permitting ΔQuickDASH-JSSH to be calculated. Among them, 1431 patients were excluded because they were either in stable remission throughout the survey period or the DAS28 could not be collected during either of the survey times. In the 2667 evaluable patients, 34 had a good response, 903 had a moderate response, and 1730 had no response. The mean ΔQuickDASH-JSSH values for good, moderate, and no response were ⫺ 6.89 (SD, 8.08), ⫺ 5.35 (SD, 11.3), and 0.91 (SD, 11.4), respectively. There was a significant difference in the ΔQuickDASHJSSH values of these three groups (P ⬍ 0.01) (Figure 2).

Discussion In this study, we first compared the reliability and validity of QuickDASH-JSSH and DASH-JSSH by using our cohort of 94 Table 3. Pearson’s correlation coefficient between QuickDASH-JSSH, J-HAQ, DAS28, pain VAS, serum CRP level, and ESR. J-HAQ DAS28 Pain VAS CRP ESR

Quick DASH-JSSH 0.88 0.53 0.63 0.25 0.30

J-HAQ – 0.49 0.56 0.23 0.31

QuickDASH Quick Disabilities of the Arm, Shoulder and Hand, DAS Disease Activity Score, J-HAQ Japanese version of Health Assessment Questionnaire, VAS visual analogue scale, CRP C-reactive protein, ESR erythrocyte sedimentation rate

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Figure 2. Correlation between changes in the QuickDASH score and EULAR response (from October 2008 to October 2009).

patients with RA and upper extremity impairment. The scores for QuickDASH-JSSH and DASH-JSSH were highly correlated with each other. Moreover, the response rate of patients aged ⱖ 65 years was higher for QuickDASH-JSSH than for DASH-JSSH. As a result, the response rate for QuickDASH-JSSH was higher than that for DASH-JSSH, indicating that QuickDASH-JSSH is a suitable tool for evaluating upper extremity impairment in patients with RA, especially in a cohort including elderly patients. Based on this result, we next applied QuickDASH-JSSH to our IORRA cohort of 5191 Japanese patients with RA. The response rate for QuickDASH-JSSH was 95.3%, and this questionnaire had a good correlation with DAS28, J-HAQ, and the DAS28-based EULAR response. Our results indicated that QuickDASH is a suitable assessment tool for the upper extremity function of patient with RA, and it also represents disease activity, the disability index, and disease control in a large cohort of patients with RA including elderly patients. High response rates are important for cohort studies [2,20]. The response rate for QuickDASH-JSSH was significantly higher than that for DASH-JSSH in patients older than 65 years old. This result coincided with a previous report revealing that the response rate for QuickDASH-JSSH is higher than that for DASH-JSSH, especially in elderly and functionally impaired non-RA individuals. One of the reasons for this finding may be that QuickDASH-JSSH is short and easier to complete than DASH-JSSH, and the recreational and sexual activity items are eliminated from QuickDASH-JSSH [16]. The response rate for QuickDASH-JSSH was as high as 95.3% in our IORRA cohort, which also supported their conclusion that QuickDASH-JSSH is suitable for a large cohort studies that include elderly and functionally impaired individuals [16]. In our IORRA cohort of 5191 Japanese patients with RA, QuickDASH-JSSH correlated with DAS28 and VAS for pain. This result coincided with previous studies of 102 Dutch and 166 Turkish patients with RA, which identified a correlation between DASH and DAS28 [10,11]. Moreover, in our IORRA study, these correlations were higher in QuickDASH-JSSH than in J-HAQ (Table 3). This suggests that disease activity and pain are more likely to be reflected in upper extremity disability than in total physical disability. One of the reasons for this observation may be that every patient uses his/her upper extremities in almost every daily activity. On the contrary, disability of the lower extremities and/or trunk may have less influence on patient function because at least some activities can be performed while sitting. Therefore, it is understandable that disability of the upper extremities is highly correlated with disease activity and

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pain compared with total physical impairment. The correlation between QuickDASH-JSSH and J-HAQ was also strong in the IORRA cohort, similar to that observed between DASH and HAQ in other RA populations [10,11]. One of the reasons for this high correlation might be that 12 of the 20 items in J-HAQ are directly related to upper extremity function. There was a significant correlation between ΔQuickDASHJSSH and DAS28-based EULAR response in our IORRA cohort. This indicates that the QuickDASH-JSSH may represent control of RA in addition to disease activity and disability index. In addition, the correlation between QuickDASH-JSSH and DAS28 was stronger in patients whose disease duration was ⬍ 5 years (r ⫽ 0.61) than in whose disease duration was ⱖ 15 years (r ⫽ 0.49). This may indicate that upper extremity function in patients with RA is more likely to improve with good disease control in those whose disease duration is rather short, similar to the concept of “windows of opportunity”. We previously demonstrated that the J-HAQ score did not change in our patients with RA who had undergone surgical procedures, suggesting that the outcome of surgical treatment could be better assessed by tools other than J-HAQ [4]. In the upper extremities, a previous study demonstrated that DASH-JSSH could be a useful tool for evaluating the outcome of surgical treatment in patients with RA [12]. As QuickDASH-JSSH has a high correlation with DASH-JSSH in patients with RA, QuickDASH-JSSH may also be a useful tool for evaluating the outcome of surgical treatment of the upper extremities. There are several limitations in this study. First, both the upper extremity impairment and IORRA cohort studies were single-institution-based studies. As our institution is located in midtown Tokyo, Japan, our patients are primarily consisted of those who could use public transportation or walk to our institution. Patients with severe functional impairment were likely to be excluded from our cohort. Next, the reliability and intra-class correlations of DASH-JSSH and QuickDASH-JSSH were examined in only 17 patients who responded to both questionnaires. We also did not apply the full version of DASH-JSSH to our IORRA cohort. In conclusion, QuickDASH appears to be a suitable assessment tool for upper extremity impairment in a large cohort of patients with RA that includes elderly patients. QuickDASH correlated well with DAS28 and DAS28-based EULAR response. Efficient management of RA should reduce both functional disability and upper extremity impairment.

Acknowledgement We would like to thank to all other members in the Institute of Rheumatology, Tokyo Women’s Medical University. We also thank Prof. Y. Toyama and other members of the Department of Orthopedic Surgery, Keio University School of Medicine for their support. This work was supported in part by the Japan Society for the Promotion of Science; the Japanese Society for Surgery of the Hand; the Nakatomi Foundation; the Japan Orthopaedics and Traumatology Foundation, Inc. No. 277; and the Japanese Osteoporosis Foundation to K.O.

Conflict of interest HY has received honorarium for the lecture from AbbVie, Chugai, Daiichi Sankyo, Eisai, Mitsubishi Tanabe, Pfizer, Takeda, Teijin Pharma. The rest of the authors have no conflict of interest to state.

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Construct validity, reliability, response rate, and association with disease activity of the quick disabilities of the arm, shoulder and hand questionnaire in the assessment of rheumatoid arthritis.

First objective is to validate the Disabilities of the Arm, Shoulder and Hand (DASH) and Quick DASH (QuickDASH) questionnaire in rheumatoid arthritis ...
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