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Minimum clinically important change for outcome scores among patients aged 75 or over undergoing lumbar spine surgery

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Abstract

Purpose

To elucidate the minimum clinically important change (MCIC) of the physical component summary (PCS) of the Short Form-12, Oswestry Disability Index (ODI), EuroQOL-5 dimensions (EQ-5D), and the Core Outcome Measures Index (COMI) in patients aged ≥ 75 years undergoing lumbar spine surgery.

Methods

We retrospectively reviewed patients aged ≥ 75 years with degenerative lumbar spine disease who underwent lumbar spine decompression or fusion surgery within three levels between April 2017 and June 2018. We also evaluated patients aged < 75 years in the same period as reference. We evaluated the baseline and postoperative PCS, ODI, EQ-5D, and COMI scores. Patients were asked to answer an anchor question regarding health transition for MCICs using the anchor-based method.

Results

A total of 247 patients aged ≥ 75 years and 398 patients aged < 75 years were included for analysis. Of patients aged ≥ 75 years, 83.4% showed at least “somewhat improved” outcomes, while 91.0% of patients aged < 75 years reported this outcome. PCS change score was not adequately correlated to health transition in patients aged ≥ 75 years. Receiver operating characteristic curve analyses revealed MCICs of 17.8 for ODI, 0.18 for EQ-5D, and 1.6 for COMI in patients aged ≥ 75 years, and 12.7 for ODI, 0.19 for EQ-5D, and 2.3 for COMI in patients aged < 75 years.

Conclusion

In patients aged ≥ 75 years, PCS may not be feasible for evaluation of health transition. The MCIC value for ODI score was higher and that for EQ-5D/COMI score was lower in patients aged ≥ 75 years, compared with those in patients aged < 75 years.

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Funding

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Author information

Authors and Affiliations

  1. Department of Orthopaedic Surgery and Spinal Surgery, The University of Tokyo Hospital, 7-3-1, Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan

    Kosei Nagata, Hideki Nakamoto, So Kato, Sakae Tanaka & Yasushi Oshima

  2. University of Tokyo Spine Group (UTSG), 7-3-1, Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan

    Kosei Nagata, Hideki Nakamoto, So Kato, Yujiro Takeshita, Naohiro Kawamura, Takashi Ono, Akiro Higashikawa, Masayoshi Fukushima, Seiichi Azuma, Nobuhiro Hara, Hiroyuki Oka, Ko Matsudaira & Yasushi Oshima

  3. Department of Orthopedic Surgery, Yokohama Rosai Hospital, 3211, Kozukue-Cho, Kohoku-Ku, Yokohama City, Kanagawa,, 222-0036, Japan

    Yujiro Takeshita

  4. Department of Spine and Orthopedic Surgery, Japanese Red Cross Medical Center, 4-2, Hiroo, Shibuya-Ku, Tokyo, 150-8935, Japan

    Naohiro Kawamura

  5. Department of Spinal Surgery, Japan Community Health-Care Organization Tokyo Shinjuku Medical Center, 5-1, Tsukudo-Cho, Shinjuku-Ku, Tokyo, 162-8543, Japan

    Takashi Ono

  6. Department of Orthopedic Surgery, Kanto Rosai Hospital, 1-1, Kizukisumiyoshi-Cho, Nakahaha-Ku, Kawasaki City, Kanagawa, 211-8510, Japan

    Akiro Higashikawa

  7. Spine Center, Toranomon Hospital, 2-2-2, Toranomon, Minato-Ku, Tokyo, 105-8470, Japan

    Masayoshi Fukushima

  8. Department of Orthopedic Surgery, Japanese Red Cross Saitama Hospital, 1-5, Shintoshin, Chuo-Ku, Saitama City, Saitama, 330-8553, Japan

    Seiichi Azuma

  9. Department of Orthopedic Surgery, Japanese Red Cross Musashino Hospital, 1-26-1, Kyonancho, Musashino City, Tokyo, 180-0023, Japan

    Nobuhiro Hara

  10. Department of Medical Research and Management for Musculoskeletal Pain, Faculty of Medicine, 22Nd Century Medical and Research Center, The University of Tokyo, 7-3-1, Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan

    Hiroyuki Oka & Ko Matsudaira

Authors
  1. Kosei Nagata
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  2. Hideki Nakamoto
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  3. So Kato
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  14. Yasushi Oshima
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Contributions

KN and YO contributed to the conception and design of the study and the acquisition and interpretation of the data, and critically revised the drafted manuscript for important intellectual content. HN and SK contributed to the analysis of the data and critically revised the drafted manuscript for important intellectual content. KM, HO, and ST made substantial contributions to the conception of the study and drafted the manuscript. YT, NK, TO, AH, MF, SA, and NH contributed to the data registration and critically revised the drafted manuscript. All authors approved the final version of the manuscript to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Yasushi Oshima.

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Conflict of interest

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).

Ethical approval

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, Yokohama Rosai Hospital, Japanese Red Cross Medical Center, Japan Community Health-care Organization Tokyo Shinjuku Medical Center, Kanto Rosai Hospital, Toranomon Hospital, Saitama Red Cross Hospital, and Japanese Red Cross Musashino Hospital) and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Nagata, K., Nakamoto, H., Kato, S. et al. Minimum clinically important change for outcome scores among patients aged 75 or over undergoing lumbar spine surgery. Eur Spine J 30, 1226–1234 (2021). https://doi.org/10.1007/s00586-021-06815-2

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