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

Autor:	Hirota R; Department of Orthopaedic Surgery, School of Medicine, Sapporo Medical University, Sapporo-shi, Hokkaido, Japan.; Department of Neurology, School of Medicine, Yale University, New Haven, CT., Oshigiri T; Department of Orthopaedic Surgery, School of Medicine, Sapporo Medical University, Sapporo-shi, Hokkaido, Japan.; Department of Orthopaedic Surgery, Chitose City Hospital, Sapporo, Hokkaido, Japan., Iesato N; Department of Orthopaedic Surgery, School of Medicine, Sapporo Medical University, Sapporo-shi, Hokkaido, Japan., Emori M; Department of Orthopaedic Surgery, School of Medicine, Sapporo Medical University, Sapporo-shi, Hokkaido, Japan., Teramoto A; Department of Orthopaedic Surgery, School of Medicine, Sapporo Medical University, Sapporo-shi, Hokkaido, Japan., Shiratani Y; Department of Orthopaedic Surgery, Chiba University Hospital, Chuo-ku, Chiba-shi, Japan., Suzuki A; Department of Orthopaedic Surgery, Osaka Metropolitan University, Abeno-ku, Osaka, Japan., Terai H; Department of Orthopaedic Surgery, Osaka Metropolitan University, Abeno-ku, Osaka, Japan., Shimizu T; Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan., Kakutani K; Department of Orthopaedic Surgery, Graduate School of Medicine, Kobe University, Chuo-ku, Kobe, Japan., Kanda Y; Department of Orthopaedic Surgery, Graduate School of Medicine, Kobe University, Chuo-ku, Kobe, Japan., Tominaga H; Department of Orthopedic Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan., Kawamura I; Department of Orthopedic Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan., Ishihara M; Department of Orthopaedic Surgery, Kansai Medical University Hospital, Hirakata, Osaka, Japan., Paku M; Department of Orthopaedic Surgery, Kansai Medical University Hospital, Hirakata, Osaka, Japan., Takahashi Y; Department of Orthopaedic Surgery, School of Medicine, Keio University, Shinjuku-ku, Tokyo, Japan., Funayama T; Department of Orthopaedic Surgery, Institute of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan., Miura K; Department of Orthopaedic Surgery, Institute of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan., Shirasawa E; Department of Orthopaedic Surgery, School of Medicine, Kitasato University, Minami-ku, Sagamihara, Kanagawa, Japan., Inoue H; Department of Orthopaedics, Rehabilitation Center, Jichi Medical University Hospital, Shimotuke-shi, Japan., Kimura A; Department of Orthopaedics, Jichi Medical University, Shimotuke-shi, Japan., Iimura T; Department of Orthopaedic Surgery, Dokkyo Medical University, Mibu, Shimotsugagun, Tochigi, Japan., Moridaira H; Department of Orthopaedic Surgery, Dokkyo Medical University, Mibu, Shimotsugagun, Tochigi, Japan., Nakajima H; Department of Orthopaedics and Rehabilitation Medicine, Faculty of Medical Science, University of Fukui, Eiheiji-cho, Yoshida-gun, Fukui, Japan., Watanabe S; Department of Orthopaedics and Rehabilitation Medicine, Faculty of Medical Science, University of Fukui, Eiheiji-cho, Yoshida-gun, Fukui, Japan., Akeda K; Department of Orthopaedic Surgery, Graduate School of Medicine, Mie University, Tsu, Japan., Takegami N; Department of Orthopaedic Surgery, Graduate School of Medicine, Mie University, Tsu, Japan., Nakanishi K; Department of Orthopaedic Surgery, Kawasaki Medical School, Kurashiki, Okayama, Japan., Sawada H; Department of Orthopaedic Surgery, School of Medicine, Nihon University, Itabashi-ku, Tokyo, Japan., Matsumoto K; Department of Orthopaedic Surgery, School of Medicine, Nihon University, Itabashi-ku, Tokyo, Japan., Funaba M; Department of Orthopaedics Surgery, Graduate School of Medicine, Yamaguchi University, Ube, Yamaguchi, Japan., Suzuki H; Department of Orthopaedics Surgery, Graduate School of Medicine, Yamaguchi University, Ube, Yamaguchi, Japan., Funao H; Department of Orthopaedic Surgery, International University of Health and Welfare Narita Hospital, Narita, Chiba, Japan., Hirai T; Department of Orthopedic Surgery, Tokyo Medical and Dental University, Bunkyo‑ku, Tokyo, Japan., Otsuki B; Department of Orthopaedic Surgery, Graduate School of Medicine, Kyoto University, Sakyo, Kyoto, Japan., Kobayakawa K; Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, Higashi-ku, Fukuoka, Japan., Uotani K; Department of Orthopaedic Surgery, Okayama University Hospital, Kita-ku, Okayama-shi, Japan., Manabe H; Department of Orthopedics, Tokushima University, Kuramoto-cho, Tokushima, Japan., Tanishima S; Department of Sensory and Motor Organs, Division of Orthopedic Surgery, School of Medicine, Faculty of Medicine, Tottori University, Tottori, Japan., Hashimoto K; Department of Orthopaedic Surgery, Graduate School of Medicine, Tohoku University, Sendai, Japan., Iwai C; Department of Orthopaedic Surgery, Gifu University Hospital, Gifu, Japan., Yamabe D; Department of Orthopaedic Surgery, Iwate Medical University, Yahaba-cho, Shiwagun, Iwate, Japan., Hiyama A; Department of Orthopaedic Surgery, School of Medicine, Tokai University, Isehara, Kanagawa, Japan., Seki S; Department of Orthopaedic Surgery, University of Toyama, Toyama, Japan., Goto Y; Department of Orthopaedic Surgery, Nagoya City University, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan., Miyazaki M; Department of Orthopaedic Surgery, Faculty of Medicine, Oita University, Hasama-machi, Yufu-shi, Oita, Japan., Watanabe K; Department of Orthopaedic Surgery, School of Medicine, Fukushima Medical University, Fukushima, Japan., Nakamae T; Department of Orthopaedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Minami-ku, Hiroshima, Japan., Kaito T; Department of Orthopedic Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan., Nakashima H; Department of Orthopaedic Surgery, Graduate School of Medicine, Nagoya University, Show-ku, Nagoya, Japan., Nagoshi N; Department of Orthopaedic Surgery, School of Medicine, Keio University, Shinjuku-ku, Tokyo, Japan., Kato S; Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan., Imagama S; Department of Orthopaedic Surgery, Graduate School of Medicine, Nagoya University, Show-ku, Nagoya, Japan., Watanabe K; Department of Orthopaedic Surgery, School of Medicine, Keio University, Shinjuku-ku, Tokyo, Japan., Inoue G; Department of Orthopaedic Surgery, School of Medicine, Kitasato University, Minami-ku, Sagamihara, Kanagawa, Japan., Furuya T; Department of Orthopaedic Surgery, Chiba University Hospital, Chuo-ku, Chiba-shi, Japan.
Jazyk:	angličtina
Zdroj:	Spine [Spine (Phila Pa 1976)] 2024 Nov 15; Vol. 49 (22), pp. 1539-1547. Date of Electronic Publication: 2024 Jun 11.
DOI:	10.1097/BRS.0000000000005062
Abstrakt:	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. Level of Evidence: II. Competing Interests: The authors report no conflicts of interest. (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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