Abstract
BACKGROUND: The Carpal Tunnel Syndrome Instrument (CTSI) is a disease-specific, self-administered questionnaire that consists of a symptom severity scale (SS) and a functional status scale (FS). The CTSI was cross-culturally adapted and developed by the Impairment Evaluation Committee, Japanese Society for Surgery of the Hand (JSSH). The purpose of this study was to test the reliability, validity, and responsiveness of the Japanese version of the CTSI (CTSI-JSSH). METHODS: A consecutive series of 87 patients with carpal tunnel syndrome completed the CTSI-JSSH, the JSSH version of the Disability of the Arm, Shoulder, and Hand questionnaire (DASH-JSSH), and the 36-Item Short-Form Health Survey (SF-36). Seventy-two of the patients were reassessed for test-retest reliability 1 or 2 weeks later. Reliability was investigated by the reproducibility and the internal consistency. To analyze the validity, a factor analysis (principal axis factoring) of the CTSI-JSSH and the correlation coefficients between the CTSI-JSSH and DASH-JSSH were obtained. The responsiveness was examined by calculating the standardized response mean (SRM; mean change/SD) and effect size (mean change/SD of baseline value) after carpal tunnel release in 42 patients. RESULTS: Cronbach's alpha coefficients for the CTSI-JSSH-SS and the CTSI-JSSH-FS were 0.84 and 0.90, respectively, and the intraclass correlation coefficients were 0.82 and 0.83, respectively. The unidimensionality of the CTSI-JSSH-SS was barely confirmed; the unidimensionality of the CTSI-JSSH-FS was confirmed. The correlation coefficients between the CTSI-JSSH-FS and the CTSI-JSSH-SS or DASH-JSSH were 0.58 and 0.80, respectively. The correlation coefficient between the CTSI-JSSH-SS and DASH-JSSH was 0.54. The correlation coefficients between the subscales of SF-36 and the CTSI-JSSH-SS or the CTSI-JSSH-FS ranged from -0.23 to -0.66 and from -0.19 to -0.63, respectively. The SRMs/effect sizes of the CTSI-JSSH-SS and the CTSI-JSSH-FS were -0.85/-0.99 and -0.70/-0.61, which indicated that they were more than moderately sensitive. CONCLUSIONS: The CTSI-JSSH has sufficient reliability, validity, and responsiveness to assess the health status in carpal tunnel syndrome.