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颈椎全椎间盘置换试验中的偏倚。

Bias in cervical total disc replacement trials.

作者信息

Radcliff Kristen, Siburn Sean, Murphy Hamadi, Woods Barrett, Qureshi Sheeraz

机构信息

Department of Orthopedic Surgery, Department of Neurological Surgery, Rothman Institute, Thomas Jefferson University, 2500 English Creek Ave, Egg Harbor, NJ, 08234, USA.

Robert Wood Johnson Medical School, Rutgers University, Brunswick, NJ, USA.

出版信息

Curr Rev Musculoskelet Med. 2017 Jun;10(2):170-176. doi: 10.1007/s12178-017-9399-2.

DOI:10.1007/s12178-017-9399-2
PMID:28337733
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5435630/
Abstract

PURPOSE OF REVIEW

Cervical disc replacement (CDR) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion in selected cases. Despite favorable literature, CDR is not universally accepted because of concerns regarding bias in the existing literature. The purpose of this review is to identify the possible biases in the disc replacement literature.

RECENT FINDINGS

Recent studies that compare CDR and ACDF have demonstrated equivalent or superior outcomes, lower rates of secondary surgery, and equivalent safety at medium- and long-term follow-up. In our review, we identified four types of bias that may affect the CDR literature: publication bias, external validity, confounding bias, and financial conflicts of interest. Bias, whether intentional or unintentional, can impact the interpretation and outcome of CDR studies. Recognition of this issue is critical when utilizing the existing literature to determine the efficacy of CDR and designing future studies.

摘要

综述目的

在特定病例中,颈椎间盘置换术(CDR)已成为一种保留运动功能的替代前路颈椎间盘切除融合术的方法。尽管有相关文献支持,但由于对现有文献存在偏倚的担忧,CDR并未被普遍接受。本综述的目的是确定椎间盘置换文献中可能存在的偏倚。

最新发现

近期比较CDR和ACDF的研究表明,在中长期随访中,两者的疗效相当或更优,二次手术率更低,安全性相当。在我们的综述中,我们确定了可能影响CDR文献的四种偏倚类型:发表偏倚、外部效度、混杂偏倚和利益冲突。偏倚,无论是有意还是无意的,都可能影响CDR研究的解释和结果。在利用现有文献确定CDR的疗效以及设计未来研究时,认识到这个问题至关重要。

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1
Bias in cervical total disc replacement trials.颈椎全椎间盘置换试验中的偏倚。
Curr Rev Musculoskelet Med. 2017 Jun;10(2):170-176. doi: 10.1007/s12178-017-9399-2.
2
Cost-effectiveness analysis: comparing single-level cervical disc replacement and single-level anterior cervical discectomy and fusion: clinical article.成本效益分析:比较单节段颈椎间盘置换术与单节段前路颈椎间盘切除融合术:临床文章。
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Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial.颈椎间盘置换与前路椎间盘切除融合术治疗双节段症状性退行性椎间盘疾病的五年临床结果:一项前瞻性、随机、对照、多中心研究性器械豁免临床试验。
J Neurosurg Spine. 2016 Aug;25(2):213-24. doi: 10.3171/2015.12.SPINE15824. Epub 2016 Mar 25.

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2
Randomized controlled trials in neurosurgery.神经外科领域的随机对照试验。
Surg Neurol Int. 2022 Aug 26;13:379. doi: 10.25259/SNI_1032_2021. eCollection 2022.
3
Effect of Arthroplasty vs Fusion for Patients With Cervical Radiculopathy: A Randomized Clinical Trial.人工关节置换与融合治疗神经根型颈椎病的随机临床试验
JAMA Netw Open. 2021 Aug 2;4(8):e2119606. doi: 10.1001/jamanetworkopen.2021.19606.
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Unintended fusion in cervical artificial disk replacement: a prospective study on heterotopic ossification, progression, and clinical outcome, with 5-year follow-up.颈椎人工椎间盘置换术中的非预期融合:一项关于异位骨化、进展和临床结果的前瞻性研究,随访 5 年。
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Economics of Cervical Disc Replacement.颈椎间盘置换的经济学
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Artificial disc replacement in spine surgery.脊柱手术中的人工椎间盘置换
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本文引用的文献

1
Commercial conflict of interest and medical publication: What should the practising physician do about it?商业利益冲突与医学出版:执业医师对此应如何应对?
Indian J Med Ethics. 2016 Oct-Dec;1(4):227-228. doi: 10.20529/IJME.2016.066. Epub 2016 Sep 14.
2
Adjacent segment degeneration following ProDisc-C total disc replacement (TDR) and anterior cervical discectomy and fusion (ACDF): does surgeon bias effect radiographic interpretation?ProDisc-C全椎间盘置换术(TDR)及颈椎前路椎间盘切除融合术(ACDF)后相邻节段退变:外科医生的偏好是否会影响影像学解读?
Eur Spine J. 2017 Apr;26(4):1199-1204. doi: 10.1007/s00586-016-4780-1. Epub 2016 Sep 20.
3
Conflict of interest and bias in publication.出版中的利益冲突与偏见。
Indian J Med Ethics. 2016 Oct-Dec;1(4):219-222. doi: 10.20529/IJME.2016.063. Epub 2016 Aug 8.
4
Total disc replacement versus fusion for lumbar degenerative disc disease: a systematic review of overlapping meta-analyses.腰椎退行性椎间盘疾病的全椎间盘置换术与融合术:重叠荟萃分析的系统评价
Eur Spine J. 2017 Mar;26(3):806-815. doi: 10.1007/s00586-016-4714-y. Epub 2016 Jul 23.
5
Cervical Disc Arthroplasty with Prestige LP Disc Versus Anterior Cervical Discectomy and Fusion: Seven-Year Outcomes.使用 Prestige LP 椎间盘的颈椎间盘置换术与颈椎前路椎间盘切除融合术:七年随访结果
Int J Spine Surg. 2016 Jun 22;10:24. doi: 10.14444/3024. eCollection 2016.
6
The New England Journal of Medicine: commercial conflict of interest and revisiting the Vioxx scandal.《新英格兰医学杂志》:商业利益冲突与对万络丑闻的重新审视。
Indian J Med Ethics. 2016 Jul-Sep;1(3):167-71. doi: 10.20529/IJME.2016.046. Epub 2016 Jun 15.
7
Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up.单节段Mobi-C颈椎全椎间盘置换术与颈椎前路椎间盘切除融合术的前瞻性随机对照研究:5年随访结果
Int J Spine Surg. 2016 Feb 26;10:10. doi: 10.14444/3010. eCollection 2016.
8
Fulfillment of patients' expectations of lumbar and cervical spine surgery.满足患者对腰椎和颈椎手术的期望。
Spine J. 2016 Oct;16(10):1167-1174. doi: 10.1016/j.spinee.2016.04.011. Epub 2016 Apr 18.
9
Improvement in Pain After Lumbar Spine Surgery: The Role of Preoperative Expectations of Pain Relief.腰椎手术后疼痛的改善:术前疼痛缓解期望的作用。
Clin J Pain. 2017 Feb;33(2):93-98. doi: 10.1097/AJP.0000000000000383.
10
Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial.颈椎间盘置换与前路椎间盘切除融合术治疗双节段症状性退行性椎间盘疾病的五年临床结果:一项前瞻性、随机、对照、多中心研究性器械豁免临床试验。
J Neurosurg Spine. 2016 Aug;25(2):213-24. doi: 10.3171/2015.12.SPINE15824. Epub 2016 Mar 25.