Prospective Registration Study for Establishing Minimal Clinically Important Differences in Patients Undergoing Surgery for Spinal Metastases

Ryosuke Hirota; Tsutomu Oshigiri; Noriyuki Iesato; Makoto Emori; Atsushi Teramoto; Yuki Shiratani; Akinobu Suzuki; Hidetomi Terai; Takaki Shimizu; Kenichiro Kakutani; Yutaro Kanda; Hiroyuki Tominaga; Ichiro Kawamura; Masayuki Ishihara; Masaaki Paku; Yohei Takahashi; Toru Funayama; Kousei Miura; Eiki Shirasawa; Hirokazu Inoue; Atsushi Kimura; Takuya Iimura; Hiroshi Moridaira; Hideaki Nakajima; Shuji Watanabe; Koji Akeda; Norihiko Takegami; Kazuo Nakanishi; Hirokatsu Sawada; Koji Matsumoto; Masahiro Funaba; Hidenori Suzuki; Haruki Funao; Takashi Hirai; Bungo Otsuki; Kazu Kobayakawa; Koji Uotani; Hiroaki Manabe; Shinji Tanishima; Ko Hashimoto; Chizuo Iwai; Daisuke Yamabe; Akihiko Hiyama; Shoji Seki; Yuta Goto; Masashi Miyazaki; Kazuyuki Watanabe; Toshio Nakamae; Takashi Kaito; Hiroaki Nakashima; Narihito Nagoshi; Satoshi Kato; Shiro Imagama; Kota Watanabe; Gen Inoue; Takeo Furuya

doi:10.1097/BRS.0000000000005062

Prospective Registration Study for Establishing Minimal Clinically Important Differences in Patients Undergoing Surgery for Spinal Metastases

Ryosuke Hirota^*, Tsutomu Oshigiri, Noriyuki Iesato, Makoto Emori, Atsushi Teramoto, Yuki Shiratani, Akinobu Suzuki, Hidetomi Terai, Takaki Shimizu, Kenichiro Kakutani, Yutaro Kanda, Hiroyuki Tominaga, Ichiro Kawamura, Masayuki Ishihara, Masaaki Paku, Yohei Takahashi, Toru Funayama, Kousei Miura, Eiki Shirasawa, Hirokazu InoueAtsushi Kimura, Takuya Iimura, Hiroshi Moridaira, Hideaki Nakajima, Shuji Watanabe, Koji Akeda, Norihiko Takegami, Kazuo Nakanishi, Hirokatsu Sawada, Koji Matsumoto, Masahiro Funaba, Hidenori Suzuki, Haruki Funao, Takashi Hirai, Bungo Otsuki, Kazu Kobayakawa, Koji Uotani, Hiroaki Manabe, Shinji Tanishima, Ko Hashimoto, Chizuo Iwai, Daisuke Yamabe, Akihiko Hiyama, Shoji Seki, Yuta Goto, Masashi Miyazaki, Kazuyuki Watanabe, Toshio Nakamae, Takashi Kaito, Hiroaki Nakashima, Narihito Nagoshi, Satoshi Kato, Shiro Imagama, Kota Watanabe, Gen Inoue, Takeo Furuya

^*Corresponding author for this work

Orthopaedic Surgery

Research output: Contribution to journal › Article › peer-review

Abstract

Study Design. Multicenter, prospective registry study. Objective. To clarify minimal clinically important differences (MCIDs) for surgical interventions for spinal metastases, thereby enhancing patient care by integrating quality of life assessments with clinical outcomes. Background. Despite its proven usefulness in degenerative spinal diseases and deformities, the MCID remains unexplored regarding surgery for spinal metastases. Patients and Methods. This study included 171 (out of 413) patients from the multicenter "Prospective Registration Study on Surgery for Metastatic Spinal Tumors"by the Japan Association of Spine Surgeons. These were evaluated preoperatively and at 6 months postoperatively using the Face Scale, EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), including the Visual Analog Scale, and performance status. The MCIDs were calculated using an anchor-based method, classifying participants into the improved, unchanged, and deteriorated groups based on the Face Scale scores. Focusing on the improved and unchanged groups, the change in the EQ-5D-5L values from before to after treatment was analyzed, and the cutoff value with the highest sensitivity and specificity was determined as the MCID through receiver operating characteristic curve analysis. The validity of the MCIDs was evaluated using a distribution-based calculation method for patient-reported outcomes. Results. The improved, unchanged, and deteriorated groups comprised 121, 28, and 22 participants, respectively. The anchor-based MCIDs for the EQ-5D-5L index, EQ-Visual Analog Scale, and domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were 0.21, 15.50, 1.50, 0.50, 0.50, 0.50, and 0.50, respectively; the corresponding distribution-based MCIDs were 0.17, 15,99, 0.77, 0.80, 0.78, 0.60, and 0.70, respectively. Conclusion. We identified MCIDs for surgical treatment of spinal metastases, providing benchmarks for future clinical research. By retrospectively examining whether the MCIDs are achieved, factors favoring their achievement and risks affecting them can be explored. This could aid in decisions on surgical candidacy and patient counseling.

Original language	English
Pages (from-to)	1539-1547
Number of pages	9
Journal	Spine
Volume	49
Issue number	22
DOIs	https://doi.org/10.1097/BRS.0000000000005062
State	Published - 2024/11/15

Keywords

EQ-5D-5L
Face Scale
MCID
anchor method
cancer
distribution method
patient-reported outcomes
spinal metastasis
surgery

ASJC Scopus subject areas

Orthopedics and Sports Medicine
Clinical Neurology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1097/BRS.0000000000005062

Cite this

Hirota, R., Oshigiri, T., Iesato, N., Emori, M., Teramoto, A., Shiratani, Y., Suzuki, A., Terai, H., Shimizu, T., Kakutani, K., Kanda, Y., Tominaga, H., Kawamura, I., Ishihara, M., Paku, M., Takahashi, Y., Funayama, T., Miura, K., Shirasawa, E., ... Furuya, T. (2024). Prospective Registration Study for Establishing Minimal Clinically Important Differences in Patients Undergoing Surgery for Spinal Metastases. Spine, 49(22), 1539-1547. https://doi.org/10.1097/BRS.0000000000005062

@article{decbb0fe90034da68a59d69a63e85539,

title = "Prospective Registration Study for Establishing Minimal Clinically Important Differences in Patients Undergoing Surgery for Spinal Metastases",

abstract = "Study Design. Multicenter, prospective registry study. Objective. To clarify minimal clinically important differences (MCIDs) for surgical interventions for spinal metastases, thereby enhancing patient care by integrating quality of life assessments with clinical outcomes. Background. Despite its proven usefulness in degenerative spinal diseases and deformities, the MCID remains unexplored regarding surgery for spinal metastases. Patients and Methods. This study included 171 (out of 413) patients from the multicenter {"}Prospective Registration Study on Surgery for Metastatic Spinal Tumors{"}by the Japan Association of Spine Surgeons. These were evaluated preoperatively and at 6 months postoperatively using the Face Scale, EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), including the Visual Analog Scale, and performance status. The MCIDs were calculated using an anchor-based method, classifying participants into the improved, unchanged, and deteriorated groups based on the Face Scale scores. Focusing on the improved and unchanged groups, the change in the EQ-5D-5L values from before to after treatment was analyzed, and the cutoff value with the highest sensitivity and specificity was determined as the MCID through receiver operating characteristic curve analysis. The validity of the MCIDs was evaluated using a distribution-based calculation method for patient-reported outcomes. Results. The improved, unchanged, and deteriorated groups comprised 121, 28, and 22 participants, respectively. The anchor-based MCIDs for the EQ-5D-5L index, EQ-Visual Analog Scale, and domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were 0.21, 15.50, 1.50, 0.50, 0.50, 0.50, and 0.50, respectively; the corresponding distribution-based MCIDs were 0.17, 15,99, 0.77, 0.80, 0.78, 0.60, and 0.70, respectively. Conclusion. We identified MCIDs for surgical treatment of spinal metastases, providing benchmarks for future clinical research. By retrospectively examining whether the MCIDs are achieved, factors favoring their achievement and risks affecting them can be explored. This could aid in decisions on surgical candidacy and patient counseling.",

keywords = "EQ-5D-5L, Face Scale, MCID, anchor method, cancer, distribution method, patient-reported outcomes, spinal metastasis, surgery",

author = "Ryosuke Hirota and Tsutomu Oshigiri and Noriyuki Iesato and Makoto Emori and Atsushi Teramoto and Yuki Shiratani and Akinobu Suzuki and Hidetomi Terai and Takaki Shimizu and Kenichiro Kakutani and Yutaro Kanda and Hiroyuki Tominaga and Ichiro Kawamura and Masayuki Ishihara and Masaaki Paku and Yohei Takahashi and Toru Funayama and Kousei Miura and Eiki Shirasawa and Hirokazu Inoue and Atsushi Kimura and Takuya Iimura and Hiroshi Moridaira and Hideaki Nakajima and Shuji Watanabe and Koji Akeda and Norihiko Takegami and Kazuo Nakanishi and Hirokatsu Sawada and Koji Matsumoto and Masahiro Funaba and Hidenori Suzuki and Haruki Funao and Takashi Hirai and Bungo Otsuki and Kazu Kobayakawa and Koji Uotani and Hiroaki Manabe and Shinji Tanishima and Ko Hashimoto and Chizuo Iwai and Daisuke Yamabe and Akihiko Hiyama and Shoji Seki and Yuta Goto and Masashi Miyazaki and Kazuyuki Watanabe and Toshio Nakamae and Takashi Kaito and Hiroaki Nakashima and Narihito Nagoshi and Satoshi Kato and Shiro Imagama and Kota Watanabe and Gen Inoue and Takeo Furuya",

year = "2024",

month = nov,

day = "15",

doi = "10.1097/BRS.0000000000005062",

language = "英語",

volume = "49",

pages = "1539--1547",

journal = "Spine",

issn = "0362-2436",

publisher = "Wolters Kluwer Health",

number = "22",

}

Hirota, R, Oshigiri, T, Iesato, N, Emori, M, Teramoto, A, Shiratani, Y, Suzuki, A, Terai, H, Shimizu, T, Kakutani, K, Kanda, Y, Tominaga, H, Kawamura, I, Ishihara, M, Paku, M, Takahashi, Y, Funayama, T, Miura, K, Shirasawa, E, Inoue, H, Kimura, A, Iimura, T, Moridaira, H, Nakajima, H, Watanabe, S, Akeda, K, Takegami, N, Nakanishi, K, Sawada, H, Matsumoto, K, Funaba, M, Suzuki, H, Funao, H, Hirai, T, Otsuki, B, Kobayakawa, K, Uotani, K, Manabe, H, Tanishima, S, Hashimoto, K, Iwai, C, Yamabe, D, Hiyama, A, Seki, S, Goto, Y, Miyazaki, M, Watanabe, K, Nakamae, T, Kaito, T, Nakashima, H, Nagoshi, N, Kato, S, Imagama, S, Watanabe, K, Inoue, G & Furuya, T 2024, 'Prospective Registration Study for Establishing Minimal Clinically Important Differences in Patients Undergoing Surgery for Spinal Metastases', Spine, vol. 49, no. 22, pp. 1539-1547. https://doi.org/10.1097/BRS.0000000000005062

TY - JOUR

T1 - Prospective Registration Study for Establishing Minimal Clinically Important Differences in Patients Undergoing Surgery for Spinal Metastases

AU - Hirota, Ryosuke

AU - Oshigiri, Tsutomu

AU - Iesato, Noriyuki

AU - Emori, Makoto

AU - Teramoto, Atsushi

AU - Shiratani, Yuki

AU - Suzuki, Akinobu

AU - Terai, Hidetomi

AU - Shimizu, Takaki

AU - Kakutani, Kenichiro

AU - Kanda, Yutaro

AU - Tominaga, Hiroyuki

AU - Kawamura, Ichiro

AU - Ishihara, Masayuki

AU - Paku, Masaaki

AU - Takahashi, Yohei

AU - Funayama, Toru

AU - Miura, Kousei

AU - Shirasawa, Eiki

AU - Inoue, Hirokazu

AU - Kimura, Atsushi

AU - Iimura, Takuya

AU - Moridaira, Hiroshi

AU - Nakajima, Hideaki

AU - Watanabe, Shuji

AU - Akeda, Koji

AU - Takegami, Norihiko

AU - Nakanishi, Kazuo

AU - Sawada, Hirokatsu

AU - Matsumoto, Koji

AU - Funaba, Masahiro

AU - Suzuki, Hidenori

AU - Funao, Haruki

AU - Hirai, Takashi

AU - Otsuki, Bungo

AU - Kobayakawa, Kazu

AU - Uotani, Koji

AU - Manabe, Hiroaki

AU - Tanishima, Shinji

AU - Hashimoto, Ko

AU - Iwai, Chizuo

AU - Yamabe, Daisuke

AU - Hiyama, Akihiko

AU - Seki, Shoji

AU - Goto, Yuta

AU - Miyazaki, Masashi

AU - Watanabe, Kazuyuki

AU - Nakamae, Toshio

AU - Kaito, Takashi

AU - Nakashima, Hiroaki

AU - Nagoshi, Narihito

AU - Kato, Satoshi

AU - Imagama, Shiro

AU - Watanabe, Kota

AU - Inoue, Gen

AU - Furuya, Takeo

PY - 2024/11/15

Y1 - 2024/11/15

N2 - Study Design. Multicenter, prospective registry study. Objective. To clarify minimal clinically important differences (MCIDs) for surgical interventions for spinal metastases, thereby enhancing patient care by integrating quality of life assessments with clinical outcomes. Background. Despite its proven usefulness in degenerative spinal diseases and deformities, the MCID remains unexplored regarding surgery for spinal metastases. Patients and Methods. This study included 171 (out of 413) patients from the multicenter "Prospective Registration Study on Surgery for Metastatic Spinal Tumors"by the Japan Association of Spine Surgeons. These were evaluated preoperatively and at 6 months postoperatively using the Face Scale, EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), including the Visual Analog Scale, and performance status. The MCIDs were calculated using an anchor-based method, classifying participants into the improved, unchanged, and deteriorated groups based on the Face Scale scores. Focusing on the improved and unchanged groups, the change in the EQ-5D-5L values from before to after treatment was analyzed, and the cutoff value with the highest sensitivity and specificity was determined as the MCID through receiver operating characteristic curve analysis. The validity of the MCIDs was evaluated using a distribution-based calculation method for patient-reported outcomes. Results. The improved, unchanged, and deteriorated groups comprised 121, 28, and 22 participants, respectively. The anchor-based MCIDs for the EQ-5D-5L index, EQ-Visual Analog Scale, and domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were 0.21, 15.50, 1.50, 0.50, 0.50, 0.50, and 0.50, respectively; the corresponding distribution-based MCIDs were 0.17, 15,99, 0.77, 0.80, 0.78, 0.60, and 0.70, respectively. Conclusion. We identified MCIDs for surgical treatment of spinal metastases, providing benchmarks for future clinical research. By retrospectively examining whether the MCIDs are achieved, factors favoring their achievement and risks affecting them can be explored. This could aid in decisions on surgical candidacy and patient counseling.

AB - Study Design. Multicenter, prospective registry study. Objective. To clarify minimal clinically important differences (MCIDs) for surgical interventions for spinal metastases, thereby enhancing patient care by integrating quality of life assessments with clinical outcomes. Background. Despite its proven usefulness in degenerative spinal diseases and deformities, the MCID remains unexplored regarding surgery for spinal metastases. Patients and Methods. This study included 171 (out of 413) patients from the multicenter "Prospective Registration Study on Surgery for Metastatic Spinal Tumors"by the Japan Association of Spine Surgeons. These were evaluated preoperatively and at 6 months postoperatively using the Face Scale, EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), including the Visual Analog Scale, and performance status. The MCIDs were calculated using an anchor-based method, classifying participants into the improved, unchanged, and deteriorated groups based on the Face Scale scores. Focusing on the improved and unchanged groups, the change in the EQ-5D-5L values from before to after treatment was analyzed, and the cutoff value with the highest sensitivity and specificity was determined as the MCID through receiver operating characteristic curve analysis. The validity of the MCIDs was evaluated using a distribution-based calculation method for patient-reported outcomes. Results. The improved, unchanged, and deteriorated groups comprised 121, 28, and 22 participants, respectively. The anchor-based MCIDs for the EQ-5D-5L index, EQ-Visual Analog Scale, and domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were 0.21, 15.50, 1.50, 0.50, 0.50, 0.50, and 0.50, respectively; the corresponding distribution-based MCIDs were 0.17, 15,99, 0.77, 0.80, 0.78, 0.60, and 0.70, respectively. Conclusion. We identified MCIDs for surgical treatment of spinal metastases, providing benchmarks for future clinical research. By retrospectively examining whether the MCIDs are achieved, factors favoring their achievement and risks affecting them can be explored. This could aid in decisions on surgical candidacy and patient counseling.

KW - EQ-5D-5L

KW - Face Scale

KW - MCID

KW - anchor method

KW - cancer

KW - distribution method

KW - patient-reported outcomes

KW - spinal metastasis

KW - surgery

UR - http://www.scopus.com/inward/record.url?scp=85208203857&partnerID=8YFLogxK

U2 - 10.1097/BRS.0000000000005062

DO - 10.1097/BRS.0000000000005062

M3 - 学術論文

C2 - 38857372

AN - SCOPUS:85208203857

SN - 0362-2436

VL - 49

SP - 1539

EP - 1547

JO - Spine

JF - Spine

IS - 22

ER -

Prospective Registration Study for Establishing Minimal Clinically Important Differences in Patients Undergoing Surgery for Spinal Metastases

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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