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

IF 2.6 2区医学 Q2 CLINICAL NEUROLOGY Spine Pub Date : 2024-11-15 Epub Date: 2024-06-11 DOI:10.1097/BRS.0000000000005062

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

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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.

Level of evidence: II.

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前瞻性注册研究：确定脊柱转移手术患者的最小临床重要差异

研究设计多中心、前瞻性登记研究：明确脊柱转移瘤手术干预的最小临床重要差异（MCID），从而通过将生活质量（QoL）评估与临床结果相结合，加强对患者的护理：背景数据摘要：尽管MCID在脊柱退行性疾病和畸形方面的作用已得到证实，但在脊柱转移瘤的手术治疗方面，MCID仍未得到探讨：本研究纳入了日本脊柱外科医生协会多中心 "转移性脊柱肿瘤手术前瞻性登记研究 "的 171 名患者（总数为 413 人）。研究人员在术前和术后 6 个月使用面容量表、EQ-5 Dimensions-5 Levels (EQ-5D-5L)（包括视觉模拟量表 (VAS)）和表现状态对这些患者进行了评估。采用基于锚的方法计算 MCID，根据面容量表得分将参与者分为病情好转组、病情不变组和病情恶化组。以改善组和不变组为重点，分析治疗前后 EQ-5D-5L 值的变化，并通过接收器操作特征曲线分析确定灵敏度和特异性最高的临界值作为 MCID。采用基于分布的患者报告结果计算方法评估了MCID的有效性：结果：病情好转组、病情不变组和病情恶化组分别有 121 名、28 名和 22 名参与者。EQ-5D-5L指数、EQ-VAS以及活动能力、自理能力、日常活动、疼痛/不适和焦虑/抑郁等领域的基于锚的MCID分别为0.21、15.50、1.50、0.50、0.50、0.50和0.50；相应的基于分布的MCID分别为0.17、15,99、0.77、0.80、0.78、0.60和0.70：我们确定了脊柱转移瘤手术治疗的MCID，为今后的临床研究提供了基准。通过回顾性检查是否达到了MCIDs，可以探索有利于达到MCIDs的因素和影响MCIDs的风险。这将有助于手术候选者的决策和患者咨询。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Spine 医学-临床神经学

CiteScore

5.90

自引率

6.70%

发文量

361

审稿时长

6.0 months

期刊介绍： Lippincott Williams & Wilkins is a leading international publisher of professional health information for physicians, nurses, specialized clinicians and students. For a complete listing of titles currently published by Lippincott Williams & Wilkins and detailed information about print, online, and other offerings, please visit the LWW Online Store. Recognized internationally as the leading journal in its field, Spine is an international, peer-reviewed, bi-weekly periodical that considers for publication original articles in the field of Spine. It is the leading subspecialty journal for the treatment of spinal disorders. Only original papers are considered for publication with the understanding that they are contributed solely to Spine. The Journal does not publish articles reporting material that has been reported at length elsewhere.