腰椎手术失败综合征患者疼痛、功能及生活质量量表中的最小临床重要差异和显著临床获益
Minimum Clinically Important Difference and Substantial Clinical Benefit in Pain, Functional, and Quality of Life Scales in Failed Back Surgery Syndrome Patients.
作者信息
Park Ki Byung, Shin Joon-Shik, Lee Jinho, Lee Yoon Jae, Kim Me-Riong, Lee Jun-Hwan, Shin Kyung-Min, Shin Byung-Cheul, Cho Jae-Heung, Ha In-Hyuk
机构信息
Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.
Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
出版信息
Spine (Phila Pa 1976). 2017 Apr 15;42(8):E474-E481. doi: 10.1097/BRS.0000000000001950.
STUDY DESIGN
.: Prospective observational 1-year study.
OBJECTIVE
.: To determine minimum clinically important difference (MCID) and substantial clinical benefit (SCB) of outcome measures in failed back surgery syndrome (FBSS) patients, as these metrics enable assessment of whether and when an intervention produces clinically meaningful effects in a patient.
SUMMARY OF BACKGROUND DATA
.: Several methods have been devised to quantify clinically important difference, but MCID and SCB for FBSS patients has yet to be determined.
METHODS
.: Patients with persisting/recurrent low back pain (LBP) and/or leg pain after lumbar surgery who completed 16 weeks of treatment (n = 105) at two hospitals in Korea from November 2011 to September 2014 were analyzed. Global perceived effect was used to determine receiver operating characteristic curves in visual analogue scale (VAS), Oswestry disability index (ODI), and short form-36 (SF-36) in an anchor-based approach.
RESULTS
.: MCIDs for ODI, LBP and leg pain VAS, physical component summary, mental health component summary (MCS), and overall health scores of SF-36 were 9.0, 22.5, 27.5, 10.2, 4.0, and 8.9, and SCBs were 15.0, 32.5, 37.0, 19.7, 19.3, and 21.1, respectively. MCID and SCB area under the curve was ≥0.8, and ≥0.7, respectively.
CONCLUSION
.: LBP and leg pain VAS, ODI, and physical component summary of SF-36 may be used to measure responsiveness in FBSS patients.
LEVEL OF EVIDENCE
研究设计
前瞻性观察性1年研究。
目的
确定失败的脊柱手术综合征（FBSS）患者结局指标的最小临床重要差异（MCID）和显著临床获益（SCB），因为这些指标能够评估干预措施是否以及何时在患者身上产生有临床意义的效果。
背景数据总结
已经设计了几种方法来量化临床重要差异，但FBSS患者的MCID和SCB尚未确定。
方法
分析了2011年11月至2014年9月在韩国两家医院完成16周治疗的腰椎手术后持续/复发性腰痛（LBP）和/或腿痛患者（n = 105）。采用基于锚定法的总体感知效应来确定视觉模拟量表（VAS）、奥斯威斯利功能障碍指数（ODI）和简明健康状况调查量表（SF-36）的受试者工作特征曲线。
结果
ODI、LBP和腿痛VAS、身体成分总结、心理健康成分总结（MCS）以及SF-36总体健康评分的MCID分别为9.0、22.5、27.5、10.2、4.0和8.9，SCB分别为15.0、32.5、37.0、19.7、19.3和21.1。曲线下MCID和SCB面积分别≥0.8和≥0.7。
结论
LBP和腿痛VAS、ODI以及SF-36身体成分总结可用于衡量FBSS患者的反应性。
证据级别
3级。
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