Department of Neurosurgery, Bergman Clinics Amsterdam, Naarden, Rijksweg 69, 1411 GE, Naarden, The Netherlands; Faculty of Medicine, University of Zurich, Zurich, Switzerland.
Faculty of Medicine, University of Zurich, Zurich, Switzerland.
Spine J. 2019 Apr;19(4):637-644. doi: 10.1016/j.spinee.2018.10.004. Epub 2018 Oct 5.
In modern clinical research, the accepted minimum follow-up for patient-reported outcome measures (PROMs) after lumbar spine surgery is 24 months, particularly after fusion. Recently, this minimum requirement has been called into question.
We aim to quantify the concordance of 1- and 2-year PROMs to evaluate the importance of long-term follow-up after elective lumbar spine surgery.
Retrospective analysis of data from a prospective registry.
We identified all patients in our prospective institutional registry who underwent degenerative lumbar spine surgery with complete baseline, 12-month, and 24-month follow-up for ODI and numeric rating scales for back and leg pain (NRS-BP and NRS-LP).
Oswestry Disability Index (ODI) and NRS-BP and NRS-LP at 1 year and at 2 years.
We evaluated concordance of 1- and 2-year change scores by means of Pearson's product-moment correlation and performed logistic regression to assess if achieving the minimum clinically important difference (MCID) at 12 months predicted 24-month MCID. Odds ratios (OR) and their 95% confidence intervals (CI), as well as model areas-under-the-curve were obtained.
A total of 210 patients were included. We observed excellent correlation among 12- and 24-month ODI (r = 0.88), NRS-LP (r = 0.76) and NRS-BP (r = 0.72, all p <.001). Equal results were obtained when stratifying for discectomy, decompression, or fusion. Patients achieving 12-month MCID were likely to achieve 24-month MCID for ODI (OR: 3.3, 95% CI: 2.4-4.1), NRS-LP (OR: 2.99, 95% CI: 2.2-4.2) and NRS-BP (OR: 3.4, 95% CI: 2.7-4.2, all p <.001) with excellent areas-under-the-curve values of 0.81, 0.77, and 0.84, respectively. Concordance rates between MCID at both follow-ups were 87.2%, 83.8%, and 84.2%. A post-hoc power analysis demonstrated sufficient statistical power.
Irrespective of the surgical procedure, 12-month PROMs for functional disability and pain severity accurately reflect those at 24 months. In support of previous literature, our results suggest that 12 months of follow-up may be sufficient for evaluating spinal patient care in clinical practice as well as in research.
在现代临床研究中，腰椎手术后患者报告结局测量（PROMs）的公认最小随访时间为 24 个月，尤其是融合术后。最近，这一最低要求受到了质疑。
我们旨在量化 1 年和 2 年 PROM 的一致性，以评估腰椎手术后长期随访的重要性。
前瞻性登记的回顾性分析。
我们从我们的前瞻性机构登记处确定了所有接受退行性腰椎手术的患者，这些患者在基线、12 个月和 24 个月时均进行 ODI 和腰背腿痛数字评分量表（NRS-BP 和 NRS-LP）的随访。
ODI 以及 1 年和 2 年时的 NRS-BP 和 NRS-LP。
我们通过 Pearson 乘积矩相关来评估 1 年和 2 年变化分数的一致性，并进行逻辑回归以评估 12 个月时是否达到最小临床重要差异（MCID）是否能预测 24 个月时的 MCID。获得了优势比（OR）及其 95%置信区间（CI），以及模型曲线下面积。
共纳入 210 例患者。我们观察到 12 个月和 24 个月 ODI（r=0.88）、NRS-LP（r=0.76）和 NRS-BP（r=0.72，均 p<0.001）之间存在极好的相关性。在椎间盘切除术、减压术或融合术之间进行分层时，也得到了相似的结果。达到 12 个月 MCID 的患者，其 ODI（OR：3.3，95%CI：2.4-4.1）、NRS-LP（OR：2.99，95%CI：2.2-4.2）和 NRS-BP（OR：3.4，95%CI：2.7-4.2，均 p<0.001）达到 24 个月 MCID 的可能性也较高，其曲线下面积分别为 0.81、0.77 和 0.84，均具有极好的预测价值。两次随访时 MCID 的一致性率分别为 87.2%、83.8%和 84.2%。事后的功效分析表明具有足够的统计学功效。
无论手术方式如何，12 个月的功能障碍和疼痛严重程度的 PROM 都能准确反映 24 个月时的情况。支持先前的文献，我们的结果表明，12 个月的随访可能足以在临床实践和研究中评估脊柱患者的护理。
