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Validity of the Japanese core outcome measures index (COMI)-neck for cervical spine surgery: a prospective cohort study

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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.

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Acknowledgement

The authors thank all the following spine surgeons who participated in data collection. H. Hasebe, S. Hirai, N Tachibana, Y Sato, S Kato, T Doi, Y Matsubayashi, and Y Taniguchi.

Funding

No funds were received in support of this work.

Author information

Authors and Affiliations

  1. Department of Orthopaedic Surgery, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

    Yasushi Oshima, Kosei Nagata, Hideki Nakamoto, Ryuji Sakamoto, Nozomu Ohtomo, Koji Nakajima & Sakae Tanaka

  2. University of Tokyo Spine Group (UTSG), Tokyo, Japan

    Yasushi Oshima, Kosei Nagata, Hideki Nakamoto, Ryuji Sakamoto, Yujiro Takeshita, Nozomu Ohtomo, Naohiro Kawamura, Masaaki Iizuka, Takashi Ono, Koji Nakajima & Akiro Higashikawa

  3. Department of Orthopedic Surgery, Yokohama Rosai Hospital, Yokohama, Japan

    Ryuji Sakamoto & Yujiro Takeshita

  4. Department of Spine and Orthopedic Surgery, Japanese Red Cross Medical Center, Tokyo, Japan

    Nozomu Ohtomo & Naohiro Kawamura

  5. Department of Spinal Surgery, Japan Community Health-Care Organization Tokyo Shinjuku Medical Center, Tokyo, Japan

    Masaaki Iizuka & Takashi Ono

  6. Department of Orthopedic Surgery, Kanto Rosai Hospital, Kawasaki, Japan

    Koji Nakajima & Akiro Higashikawa

  7. Department of Hygiene, Public Health and Preventive Medicine, Showa University School of Medicine, Tokyo, Japan

    Takahiko Yoshimoto

  8. Department of Medical Research and Management for Musculoskeletal Pain, Faculty of Medicine, 22nd Century Medical and Research Center, The University of Tokyo, Tokyo, Japan

    Tomoko Fujii, Hiroyuki Oka & Ko Matsudaira

Authors
  1. Yasushi Oshima
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  2. Kosei Nagata
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  13. Tomoko Fujii
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Corresponding author

Correspondence to Yasushi Oshima.

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No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript. The manuscript submitted does not contain information about medical device (s)/drug (s).

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee (institutional review board of the Clinical Research Support Center of the University of Tokyo Hospital) and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Oshima, Y., Nagata, K., Nakamoto, H. et al. Validity of the Japanese core outcome measures index (COMI)-neck for cervical spine surgery: a prospective cohort study. Eur Spine J 30, 402–409 (2021). https://doi.org/10.1007/s00586-020-06657-4

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  • DOI: https://doi.org/10.1007/s00586-020-06657-4

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