随访评分、变化评分或百分比变化评分用于确定手术后的临床重要结局？一项来自挪威脊柱外科登记处的观察性研究，评估了腰椎管狭窄症和腰椎退行性滑脱患者报告的结局测量指标。

Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis.

机构信息

Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland, University Hospital, Hagaviksbakken 25, 5217 Hagevik, Bergen, Norway.

Department of Clinical Medicine, University of Bergen, Christies gate 6, 5007 Bergen, Bergen, Norway.

出版信息

BMC Musculoskelet Disord. 2019 Jan 18;20(1):31. doi: 10.1186/s12891-018-2386-y.

DOI:10.1186/s12891-018-2386-y

PMID:30658613

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6339296/

Abstract

BACKGROUND

Assessment of outcomes for spinal surgeries is challenging, and an ideal measurement that reflects all aspects of importance for the patients does not exist. Oswestry Disability Index (ODI), EuroQol (EQ-5D) and Numeric Rating Scales (NRS) for leg pain and for back pain are commonly used patients reported outcome measurements (PROMs). Reporting the proportion of individuals with an outcome of clinical importance is recommended. Knowledge of the ability of PROMs to identify clearly improved patients is essential. The purpose of this study was to search cut-off criteria for PROMs that best reflect an improvement considered by the patients to be of clinical importance.

METHODS

The Global Perceived Effect scale was utilized to evaluate a clinically important outcome 12 months after surgery. The cut-offs for the PROMs that most accurately distinguish those who reported 'completely recovered' or 'much improved' from those who reported 'slightly improved', unchanged', 'slightly worse', 'much worse', or 'worse than ever' were estimated. For each PROM, we evaluated three candidate response parameters: the (raw) follow-up score, the (numerical) change score, and the percentage change score.

RESULTS

We analysed 3859 patients with Lumbar Spinal Stenosis [(LSS); mean age 66; female gender 50%] and 617 patients with Lumbar Degenerative Spondylolisthesis [(LDS); mean age 67; 72% female gender]. The accuracy of identifying 'completely recovered' and 'much better' patients was generally high, but lower for EQ-5D than for the other PROMs. For all PROMs the accuracy was lower for the change score than for the follow-up score and the percentage change score, especially among patients with low and high PROM scores at baseline. The optimal threshold for a clinically important outcome was ≤24 for ODI, ≥0.69 for EQ-5D, ≤3 for NRS leg pain, and ≤ 4 for NRS back pain, and, for the percentage change score, ≥30% for ODI, ≥40% for NRS leg pain, and ≥ 33% for NRS back pain. The estimated cut-offs were similar for LSS and for LDS.

CONCLUSION

For estimating a 'success' rate assessed by a PROM, we recommend using the follow-up score or the percentage change score. These scores reflected a clinically important outcome better than the change score.

摘要

背景

评估脊柱手术的结果具有挑战性，目前并不存在一种理想的测量方法能够反映出对患者而言所有重要的方面。Oswestry 残疾指数（ODI）、欧洲五维健康量表（EQ-5D）和腿部疼痛及背部疼痛数字评分量表（NRS）是常用的患者报告结局测量（PROM）。建议报告具有临床重要意义的结果的个体比例。了解 PROM 识别出明显改善的患者的能力至关重要。本研究的目的是寻找最佳的 PROM 截止值，以反映出患者认为具有临床重要意义的改善。

方法

利用总体感知效应量表来评估术后 12 个月的临床重要结局。估计最能准确区分那些报告“完全康复”或“明显改善”与那些报告“略有改善”、“无变化”、“略有恶化”、“明显恶化”或“比以往任何时候都差”的 PROM 的截止值。对于每个 PROM，我们评估了三个候选反应参数：（原始）随访评分、（数字）变化评分和百分比变化评分。

结果

我们分析了 3859 例腰椎管狭窄症（LSS；平均年龄 66 岁；女性占 50%）和 617 例腰椎退变性滑脱症（LDS；平均年龄 67 岁；女性占 72%）患者的资料。识别“完全康复”和“明显改善”患者的准确性通常较高，但 EQ-5D 比其他 PROM 低。对于所有 PROM，变化评分的准确性均低于随访评分和百分比变化评分，尤其是在基线 PROM 评分较低和较高的患者中。具有临床重要意义的结局的最佳阈值为 ODI≤24、EQ-5D≥0.69、NRS 腿部疼痛≤3、NRS 背部疼痛≤4，以及对于百分比变化评分，ODI≥30%、NRS 腿部疼痛≥40%和 NRS 背部疼痛≥33%。LSS 和 LDS 的估计截止值相似。