Department of Orthopaedic Surgery, University of Louisville School of Medicine;
J Neurosurg Spine. 2013 Nov;19(5):564-8. doi: 10.3171/2013.8.SPINE12804. Epub 2013 Sep 6.
Health-related quality of life (HRQOL) measures have become the mainstay for outcome appraisal in spine surgery. Clinically meaningful interpretation of HRQOL improvement has centered on the minimum clinically important difference (MCID). The purpose of this study was to calculate clinically important deterioration (CIDET) thresholds and determine a CIDET value for each HRQOL measure for patients undergoing lumbar fusion.
Seven hundred twenty-two patients (248 males, 127 smokers, mean age 60.8 years) were identified with complete preoperative and 1-year postoperative HRQOLs including the Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), and numeric rating scales (0-10) for back and leg pain following primary, instrumented, posterior lumbar fusion. Anchor-based and distribution-based methods were used to calculate CIDET for each HRQOL. Anchor-based methods included change score, change difference, and receiver operating characteristic curve analysis. The Health Transition Item, an independent item of the SF-36, was used as the external anchor. Patients who responded "somewhat worse" and "much worse" were combined and compared with patients responding "about the same." Distribution-based methods were minimum detectable change and effect size.
Diagnoses included spondylolisthesis (n = 332), scoliosis (n = 54), instability (n = 37), disc pathology (n = 146), and stenosis (n = 153). There was a statistically significant change (p < 0.0001) for each HRQOL measure from preoperatively to 1-year postoperatively. Only 107 patients (15%) reported being "somewhat worse" (n = 81) or "much worse" (n = 26). Calculation methods yielded a range of CIDET values for ODI (0.17-9.06), SF-36 physical component summary (-0.32 to 4.43), back pain (0.02-1.50), and leg pain (0.02-1.50).
A threshold for clinical deterioration was difficult to identify. This may be due to the small number of patients reporting being worse after surgery and the variability across methods to determine CIDET thresholds. Overall, it appears that patients may interpret the absence of change as deterioration.
健康相关生活质量（HRQOL）测量已成为脊柱外科结果评估的主要方法。对 HRQOL 改善的临床意义的解释主要集中在最小临床重要差异（MCID）上。本研究的目的是计算腰椎融合术后患者的临床重要恶化（CIDET）阈值，并确定每个 HRQOL 测量的 CIDET 值。
确定了 722 例患者（248 例男性，127 例吸烟者，平均年龄 60.8 岁），这些患者均具有完整的术前和术后 1 年 HRQOL，包括 Oswestry 残疾指数（ODI）、36 项简明健康调查（SF-36）以及原发性、器械辅助、后路腰椎融合术后背部和腿部疼痛的数字评分量表（0-10）。使用锚定和分布两种方法来计算每个 HRQOL 的 CIDET。锚定方法包括变化得分、变化差异和受试者工作特征曲线分析。SF-36 的独立项目“健康过渡项目”被用作外部锚。将回答“稍微差一些”和“差很多”的患者合并，并与回答“大致相同”的患者进行比较。分布方法包括最小可检测变化和效应量。
诊断包括滑椎（n = 332）、脊柱侧凸（n = 54）、不稳定（n = 37）、椎间盘病变（n = 146）和狭窄（n = 153）。每个 HRQOL 测量值从术前到术后 1 年均有统计学意义的变化（p < 0.0001）。只有 107 例患者（15%）报告“稍差”（n = 81）或“差很多”（n = 26）。计算方法得出了 ODI（0.17-9.06）、SF-36 生理成分综合评分（-0.32 至 4.43）、背部疼痛（0.02-1.50）和腿部疼痛（0.02-1.50）的 CIDET 值范围。
确定临床恶化的阈值很困难。这可能是由于术后报告恶化的患者数量较少，以及确定 CIDET 阈值的方法存在差异所致。总体而言，似乎患者会将无变化解释为恶化。
