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
Spine 2024年6月11日
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 (QoL) assessments with clinical outcomes. SUMMARY OF BACKGROUND DATA: Despite its proven usefulness in degenerative spinal diseases and deformities, the MCID remains unexplored regarding surgery for spinal metastases. 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 (VAS), 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-VAS, 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.