Werner David A T, Grotle Margreth, Gulati Sasha, Austevoll Ivar M, Lønne Greger, Nygaard Øystein P, Solberg Tore K
Department of Neurosurgery, University Hospital of Northern Norway, Tromsø, Norway.
Department of Clinical Medicine, University of Tromsø, Tromsø, Norway.
Eur Spine J. 2017 Oct;26(10):2650-2659. doi: 10.1007/s00586-017-5185-5. Epub 2017 Jun 14.
In clinical decision-making, it is crucial to discuss the probability of adverse outcomes with the patient. A large proportion of the outcomes are difficult to classify as either failure or success. Consequently, cutoff values in patient-reported outcome measures (PROMs) for "failure" and "worsening" are likely to be different from those of "non-success". The aim of this study was to identify dichotomous cutoffs for failure and worsening, 12 months after surgical treatment for lumbar disc herniation, in a large registry cohort.
A total of 6840 patients with lumbar disc herniation were operated and followed for 12 months, according to the standard protocol of the Norwegian Registry for Spine Surgery (NORspine). Patients reporting to be unchanged or worse on the Global Perceived Effectiveness (GPE) scale at 12-month follow-up were classified as "failure", and those considering themselves "worse" or "worse than ever" after surgery were classified as "worsening". These two dichotomous outcomes were used as anchors in analyses of receiver operating characteristics (ROC) to define cutoffs for failure and worsening on commonly used PROMs, namely, the Oswestry Disability Index (ODI), the EuroQuol 5D (EQ-5D), and Numerical Rating Scales (NRS) for back pain and leg pain.
"Failure" after 12 months for each PROM, as an insufficient improvement from baseline, was (sensitivity and specificity): ODI change <13 (0.82, 0.82), ODI% change <33% (0.86, 0.86), ODI final raw score >25 (0.89, 0.81), NRS back-pain change <1.5 (0.74, 0.86), NRS back-pain % change <24 (0.85, 0.81), NRS back-pain final raw score >5.5 (0.81, 0.87), NRS leg-pain change <1.5 (0.81, 0.76), NRS leg-pain % change <39 (0.86, 0.81), NRS leg-pain final raw score >4.5 (0.91, 0.85), EQ-5D change <0.10 (0.76, 0.83), and EQ-5D final raw score >0.63 (0.81, 0.85). Both a final raw score >48 for the ODI and an NRS >7.5 were indicators for "worsening" after 12 months, with acceptable accuracy.
The criteria with the highest accuracy for defining failure and worsening after surgery for lumbar disc herniation were an ODI percentage change score <33% for failure and a 12-month ODI raw score >48. These cutoffs can facilitate shared decision-making among doctors and patients, and improve quality assessment and comparison of clinical outcomes across surgical units. In addition to clinically relevant improvements, we propose that rates of failure and worsening should be included in reporting from clinical trials.
在临床决策中，与患者讨论不良结局的可能性至关重要。很大一部分结局难以简单地归类为失败或成功。因此，患者报告结局测量指标（PROMs）中“失败”和“恶化”的临界值可能与“未成功”的临界值不同。本研究的目的是在一个大型登记队列中，确定腰椎间盘突出症手术治疗12个月后失败和恶化的二分临界值。
根据挪威脊柱外科登记处（NORspine）的标准方案，共对6840例腰椎间盘突出症患者进行了手术，并随访12个月。在12个月随访时，报告全球感知有效性（GPE）量表结果未改善或变差的患者被归类为“失败”，而那些认为自己术后“变差”或“比以往任何时候都差”的患者被归类为“恶化 ”。这两个二分结局被用作分析接受者操作特征（ROC）的锚点，以确定常用PROMs（即Oswestry功能障碍指数（ODI）、欧洲五维健康量表（EQ-5D）以及背痛和腿痛数字评定量表（NRS））中失败和恶化的临界值。
每个PROM在12个月时的“失败”定义为相对于基线改善不足，其（敏感性和特异性）为：ODI变化<13（0.82，0.82），ODI%变化<33%（0.86，0.86），ODI最终原始分数>25（0.89，0.81），NRS背痛变化<1.5（0.74，0.86），NRS背痛%变化<24（0.85，0.81），NRS背痛最终原始分数>5.5（0.81，0.87），NRS腿痛变化<1.5（0.81，0.76），NRS腿痛%变化<39（0.86，0.81），NRS腿痛最终原始分数>4.5（0.91，0.85），EQ-5D变化<0.10（0.76，0.83），EQ-5D最终原始分数> 0.63（0.81，0.85）。ODI最终原始分数>48和NRS>7.5均为12个月后“恶化”的指标，准确性尚可。
定义腰椎间盘突出症手术后失败和恶化的准确性最高的标准是，失败的ODI百分比变化得分<33%，12个月的ODI原始分数>48。这些临界值有助于医生和患者之间的共同决策，并改善各手术科室临床结局的质量评估和比较。除了临床上有意义的改善外，我们建议临床试验报告中应纳入失败率和恶化率。
