Validity of the Japanese core outcome measures index (COMI)-neck for cervical spine surgery: a prospective cohort study
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ORIGINAL ARTICLE
Validity of the Japanese core outcome measures index (COMI)‑neck for cervical spine surgery: a prospective cohort study Yasushi Oshima1,2 · Kosei Nagata1,2 · Hideki Nakamoto1,2 · Ryuji Sakamoto1,2,3 · Yujiro Takeshita2,3 · Nozomu Ohtomo1,2,4 · Naohiro Kawamura2,4 · Masaaki Iizuka2,5 · Takashi Ono2,5 · Koji Nakajima1,2,6 · Akiro Higashikawa2,6 · Takahiko Yoshimoto7 · Tomoko Fujii8 · Sakae Tanaka1 · Hiroyuki Oka8 · Ko Matsudaira8 Received: 9 May 2020 / Revised: 7 October 2020 / Accepted: 3 November 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Purpose To investigate the psychometric properties of the Japanese version of the Core Outcome Measures Index-Neck (COMI-Neck) in patients undergoing cervical spine surgery. Methods A total of 177 patients undergoing cervical spine surgery for spinal disorders from April to December 2017 were enrolled. Patient-reported outcomes (PROs) included EuroQOL, Neck Disability Index, and treatment satisfaction. To address whether the questionnaire’s scores relate to other outcomes based on a predefined hypothesis, the correlations between the COMI-Neck and the other PROs were measured (Spearman’s rank correlation coefficients). The minimum clinically important difference (MCID) of the COMI summary score was calculated using the receiver operating characteristic (ROC) curve with a 7-point Likert scale of satisfaction with the treatment results. To assess reproducibility, another group of 59 volunteers with chronic neck pain were asked to reply to the COMI-Neck twice with an interval of 7–14 days. Results The COMI summary score showed no floor or ceiling effects preoperatively or postoperatively. Each of the COMI domains and the COMI summary score correlated to the hypothesized extent with the scores of the reference questionnaires (ρ = 0.40–0.79). According to the ROC curve with satisfaction (including “very satisfied” and “satisfied”), the area under the curve and MCID of the COMI summary score were 0.78 and 2.1. The intraclass correlation coefficient and the minimum detectable change (MDC 95%) of the COMI summary score were 0.97 and 0.77. Conclusion The Japanese version of the COMI-Neck is valid and reliable for Japanese-speaking patients with cervical spinal disorders. Keywords COMI · Cervical spine · Patient-reported outcome · Neck pain · Cervical myelopathy
Introduction Patients with disorders of the cervical spine can display various symptoms, such as neck and shoulder pain, numbness or clumsiness of hands, gait disturbances, and bladder disorders. Although conservative treatment is chosen in patients with mild symptoms, surgical intervention is required in patients with moderate-to-severe symptoms, particularly in those with cervical myelopathy [1–3]. Several procedures including anterior decompression and fusion, laminoplasty, and laminectomy with fusion have been proven to
* Yasushi Oshima yoo‑[email protected] Extended author information available on the last page of the article
demonstrate stable and equivalent surgical re
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