DeLong W Bradford, Polissar Nayak L, Neradilek Moni B, Laam Leslie A
Department of Neurosurgery, University of California, San Francisco, San Francisco, CA.
The Mountain-Whisper-Light Statistics, Seattle, WA.
Spine (Phila Pa 1976). 2016 Nov 15;41(22):1772-1775. doi: 10.1097/BRS.0000000000001633.
This study by Srikandarajah et al is a retrospective cohort study of 200 CES patients. Although parts of the study appear to be well done we identified serious problems that impacted their conclusions.
There is strong consensus that patients with incomplete cauda equina syndrome (CESI) should be operated upon expeditiously to prevent progression to CES with urinary retention (CESR). There is controversy concerning optimal timing of surgery in patients who have entered CESR. Some studies conclude urgent surgery for CESR does nothing to improve chance of recovery; others conclude surgery should be done within a 48 or 24-hours window after onset of bladder paralysis. Srikandarajah et al concluded that in CESI patients, decompressive surgery within 24 hours of onset of autonomic symptoms reduces bladder dysfunction at follow-up. In CESR patients, "no statistically significant difference in outcome was observed" regarding timing of surgery.
We analyzed the methods used by Srikandarajah et al to collect and analyze their data.
The primary problem with their study is that it does not consider deterioration to CESR that occurs in CESI patients over time. We also found serious problems with the methods, implementation (including numeric errors), and interpretation of the statistical analysis.
The authors' conclusion that in CESR patients, "no statistically significant difference in outcome was observed" regarding timing of surgery is not justified as a representation of their findings, because absence of statistical significance does not mean acceptance of the null hypothesis of "no effect". Their numeric results do show elevated risk of delay. We do not want to detract from the basic importance of this study, because it emphasizes the importance of operating expeditiously on patients with CESI. However, the authors' conclusions are compromised by the methodological problems.
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Srikandarajah等人开展的这项研究是对200例马尾综合征（CES）患者进行的一项回顾性队列研究。尽管该研究的部分内容似乎完成得不错，但我们发现了一些严重问题，这些问题影响了他们的结论。
人们强烈认为，不完全性马尾综合征（CESI）患者应尽快接受手术，以防止病情发展为伴有尿潴留的马尾综合征（CESR）。对于已发展为CESR的患者，手术的最佳时机存在争议。一些研究得出结论，对CESR患者进行紧急手术无助于提高恢复几率；另一些研究则得出结论，应在膀胱麻痹发作后的48或24小时内进行手术。Srikandarajah等人得出结论，在CESI患者中，自主神经症状发作后24小时内进行减压手术可减少随访时的膀胱功能障碍。在CESR患者中，关于手术时机，“未观察到结果有统计学显著差异”。
我们分析了Srikandarajah等人用于收集和分析数据的方法。
他们研究的主要问题是没有考虑CESI患者随时间推移发展为CESR的情况。我们还在统计分析的方法、实施（包括数字错误）和解释方面发现了严重问题。
作者关于在CESR患者中，手术时机“未观察到结果有统计学显著差异”的结论，作为对其研究结果的表述是不合理的，因为缺乏统计学显著性并不意味着接受“无效果”的零假设。他们的数字结果确实显示了延迟的风险增加。我们不想贬低这项研究的基本重要性，因为它强调了对CESI患者尽快进行手术的重要性。然而，作者的结论因方法学问题而受到影响。
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