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脊髓型颈椎病患者术后神经功能和生活质量最小临床重要差异的评估:一项前瞻性队列研究。

Assessment of the minimum clinically important difference in neurological function and quality of life after surgery in cervical spondylotic myelopathy patients: a prospective cohort study.

作者信息

Zhou Feifei, Zhang Yilong, Sun Yu, Zhang Fengshan, Pan Shengfa, Liu Zhongjun

机构信息

Department of Orthopedics, Peking University Third Hospital, Beijing, 100191, China.

出版信息

Eur Spine J. 2015 Dec;24(12):2918-23. doi: 10.1007/s00586-015-4208-3. Epub 2015 Sep 1.

Abstract

PURPOSE

The purpose of this study was to evaluate the application of the minimum clinically important difference (MCID) concept to postoperative clinical results by using a prospective cohort study in Chinese patients with cervical spondylotic myelopathy (CSM).

METHODS

The sample consisted of 113 patients who underwent surgical treatment for CSM in our hospital between February 2008 and November 2012. The preoperative and 1-year postoperative modified Japanese Orthopaedic Association (mJOA) scores, mJOA score recovery rate, physical component summary (PCS) and mental component summary (MCS) of the Short Form 36 were collected. The MCID of each outcome measurement was calculated by four approaches including average change, minimum detectable change, change difference and receiver operating characteristic curve. The responsiveness of each measurement was then analyzed.

RESULTS

The patients presented a statistically significant improvement (p < 0.01) postoperatively in mJOA, PCS, and MCS. The MCID calculated by four approaches varied from 4.09 to 9.62 for the PCS, 3.11 to 7.41 for the MCS, 1.25 to 3.07 for mJOA score, and 31.37 to 44.02% for mJOA recovery rate. In addition, the improvement of the mJOA score owned the highest responsiveness of the four outcome measurements.

CONCLUSIONS

The threshold value of the MCID was determined by the choice of the assessment approach. In addition, the recovery rate of the mJOA score appeared to be the most valid and responsive measure of effectiveness of surgery in CSM patients.

摘要

目的

本研究旨在通过对中国脊髓型颈椎病(CSM)患者进行前瞻性队列研究,评估最小临床重要差异(MCID)概念在术后临床结果中的应用。

方法

样本包括2008年2月至2012年11月在我院接受CSM手术治疗的113例患者。收集术前及术后1年的改良日本骨科协会(mJOA)评分、mJOA评分恢复率、简短形式36健康调查的身体成分总结(PCS)和精神成分总结(MCS)。通过平均变化、最小可检测变化、变化差异和受试者工作特征曲线四种方法计算每个结局指标的MCID。然后分析每个指标的反应性。

结果

患者术后mJOA、PCS和MCS有统计学显著改善(p < 0.01)。四种方法计算的PCS的MCID在4.09至9.62之间,MCS在3.11至7.41之间,mJOA评分为1.25至3.07,mJOA恢复率为31.37至44.02%。此外,mJOA评分的改善在四个结局指标中反应性最高。

结论

MCID的阈值由评估方法的选择决定。此外,mJOA评分恢复率似乎是CSM患者手术疗效最有效和最具反应性的指标。

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