Department of Orthopaedic Surgery, Singapore General Hospital, 20 College Rd, 169865 Singapore.
Department of Orthopaedic Surgery, Singapore General Hospital, 20 College Rd, 169865 Singapore.
Spine J. 2021 Apr;21(4):598-609. doi: 10.1016/j.spinee.2020.11.008. Epub 2020 Nov 20.
The patient acceptable symptom state (PASS) is a valuable tool for interpreting patient-reported outcomes. Previous studies have attempted to define the PASS in a heterogenous cohort with various lumbar spinal disorders and surgical procedures.
We aimed to determine the PASS threshold for the Oswestry Disability Index (ODI) specifically for patients undergoing lumbar fusion for spondylolisthesis-associated functional disability.
Retrospective review of prospectively collected registry data.
There were 692 patients who underwent primary single-level minimally invasive transforaminal lumbar interbody fusion for degenerative spondylolisthesis between 2006 and 2014.
The ODI was collected pre-operatively, at 6 months and 2 years postoperatively. An anchor question was adapted from the NASS questionnaire, "How would you rate the overall results of your treatment?" while a validation question was taken from the same questionnaire, "Has the surgery for your back condition met your expectations so far?"
Responses to the anchor question were used to determine whether a PASS was achieved. Receiver operating characteristics curve analysis was performed to assess the ability of the ODI to discriminate between an acceptable/unacceptable symptom state as well as to define PASS thresholds. Sensitivity analyses were performed for different follow-up periods (6 months, 2 years), subgroups (by age, gender, BMI, and comorbidity burden), baseline ODI tertiles, and an alternate definition of PASS.
In total, 529 of 692 (76%) patients completed 2-year follow-up, of which, 89% considered their symptom state to be acceptable. Areas under the curve (AUC) ranged from 0.81 to 0.90 for all receiver operating characteristics analyses, indicating that the ODI had an excellent discriminative ability. The PASS threshold was ≤18.09 at 6 months (AUC 0.81, sensitivity 77%, specificity 72%) and ≤15.27 at 2 years (AUC 0.86, sensitivity 79%, specificity 79%). These thresholds proved to be robust in the sensitivity analyses, showing minimal variation across different patient subgroups and baseline score tertiles.
Patients with an ODI of ≤15.27 can be considered to have achieved a PASS after lumbar fusion for degenerative spondylolisthesis. These findings will help surgeons to contextualize a patient's functional recovery after lumbar spine surgery and enable researchers to define clinically relevant benchmarks when designing trials utilizing the ODI.
患者可接受的症状状态(PASS)是解释患者报告结果的有用工具。先前的研究试图在具有各种腰椎疾病和手术的异质队列中定义 PASS。
我们旨在确定 Oswestry 残疾指数(ODI)的 PASS 阈值,专门针对因功能障碍性腰椎滑脱而接受腰椎融合术的患者。
前瞻性收集的注册表数据的回顾性研究。
共有 692 名患者在 2006 年至 2014 年间接受了单节段微创经椎间孔腰椎椎间融合术治疗退行性腰椎滑脱。
ODI 在术前、术后 6 个月和 2 年进行收集。一个锚定问题改编自 NASS 问卷,“您如何评价您的治疗总体结果?”而验证问题取自同一问卷,“到目前为止,您的背部手术是否达到了您的期望?”
使用对锚定问题的回答来确定是否达到 PASS。进行接收者操作特征曲线分析,以评估 ODI 区分可接受/不可接受症状状态的能力,以及定义 PASS 阈值。对不同的随访期(6 个月,2 年)、亚组(按年龄、性别、BMI 和合并症负担)、基线 ODI 三分位数和 PASS 的替代定义进行敏感性分析。
共有 692 名患者中的 529 名(76%)完成了 2 年随访,其中 89%的患者认为他们的症状状态可接受。所有接受者操作特征分析的曲线下面积(AUC)范围为 0.81 至 0.90,表明 ODI 具有出色的鉴别能力。6 个月时的 PASS 阈值为≤18.09(AUC 0.81,敏感性 77%,特异性 72%),2 年时的 PASS 阈值为≤15.27(AUC 0.86,敏感性 79%,特异性 79%)。这些阈值在敏感性分析中表现稳健,在不同的患者亚组和基线评分三分位数之间变化很小。
退行性腰椎滑脱患者 ODI 评分≤15.27 可被认为达到了 PASS。这些发现将帮助外科医生了解腰椎手术后患者的功能恢复情况,并使研究人员在设计使用 ODI 的试验时能够定义具有临床意义的基准。