Yakdan Salim, Frumkin Madelyn R, Javeed Saad, Plog Benjamin A, Zhang Justin K, Benedict Braeden, Botterbush Kathleen, Goodin Burel R, Piccirillo Jay F, Buchowski Jacob M, Rodebaugh Thomas L, Ray Wilson Z, Kelly Michael P, Greenberg Jacob K
Department of Neurological Surgery, Washington University, St. Louis, MO, USA.
Department of Psychological and Brain Sciences, Washington University, St. Louis, MO, USA.
Spine (Phila Pa 1976). 2025 Jan 30. doi: 10.1097/BRS.0000000000005276.
Prospective cohort study.
This study aims to define Substantial Clinical Benefit (SCB) thresholds for PROMIS physical function (PF) and pain interference (PI) in lumbar or thoracolumbar spine surgery population.
Patient-reported outcome measures (PROMs) are widely used in spine surgery to assess treatment efficacy. SCB is a relatively new concept that represents a substantial improvement perceived by the patient.
This is a prospective study that included adults aged 21-85 years, undergoing lumbar/ thoracolumbar surgery for degenerative spine disease, and reporting at least 3/10 back or leg pain on a numeric rating scale. PROMs including Oswestry Disability Index, PROMIS PF, and PROMIS PI were collected preoperatively and at one year postoperatively. The North American Spine Surgery Patient Satisfaction (NASS) Index was collected one year postoperatively. SCB thresholds of absolute and percentage changes were calculated using anchor-based methods with ODI and NASS index as anchors. ROC analysis was used to determine optimal SCB cutoffs.
We included 137 patients. Using a fixed 19-point reduction in ODI as an anchor yielded SCB thresholds of 6.8 and 11.3 points for PROMIS PF and PI respectively. When using a dynamic anchor based on preoperative disability (50% ODI improvement), SCB thresholds were defined as achieving 18 and 27% of maximum possible improvement for PROMIS PF and PI respectively. Using NASS index, thresholds were 11 points or 24% for PROMIS PF, and 11.2 points or 21% for PROMIS PI. ROC values ranged from 0.81 to 0.9, with the dynamic ODI anchor cutoffs demonstrating the best discrimination.
Our study is the first to define SCB thresholds for PROMIS PF and PROMIS PI using both fixed and dynamic cutoffs based on preoperative disability in lumbar and thoracolumbar patients. These thresholds will help in patient counseling and outcome evaluation for spine surgery research.
前瞻性队列研究。
本研究旨在确定腰椎或胸腰椎脊柱手术人群中患者报告结果测量信息系统（PROMIS）身体功能（PF）和疼痛干扰（PI）的实质性临床获益（SCB）阈值。
患者报告结局测量指标（PROMs）在脊柱手术中被广泛用于评估治疗效果。SCB是一个相对较新的概念，代表患者所感知到的实质性改善。
这是一项前瞻性研究，纳入年龄在21 - 85岁、因退行性脊柱疾病接受腰椎/胸腰椎手术且数字评分量表上背部或腿部疼痛至少为3/10的成年人。术前及术后一年收集包括奥斯威斯利功能障碍指数、PROMIS PF和PROMIS PI在内的PROMs。术后一年收集北美脊柱手术患者满意度（NASS）指数。使用以ODI和NASS指数为锚定指标的基于锚定的方法计算绝对变化和百分比变化的SCB阈值。采用ROC分析确定最佳SCB临界值。
我们纳入了137例患者。以ODI固定降低19分为锚定指标时，PROMIS PF和PI的SCB阈值分别为6.8分和11.3分。当使用基于术前功能障碍（ODI改善50%）的动态锚定指标时，PROMIS PF和PI的SCB阈值分别定义为达到最大可能改善的18%和27%。使用NASS指数时，PROMIS PF的阈值为11分或24%，PROMIS PI的阈值为11.2分或21%。ROC值范围为0.81至0.9，基于动态ODI锚定指标的临界值显示出最佳区分度。
我们的研究首次基于腰椎和胸腰椎患者的术前功能障碍，使用固定和动态临界值确定了PROMIS PF和PROMIS PI的SCB阈值。这些阈值将有助于脊柱手术研究中的患者咨询和结局评估。
