Narain Ankur S, Hijji Fady Y, Yom Kelly H, Kudaravalli Krishna T, Singh Kern
Department of Orthopedic Surgery, Rush University Medical Center, 1611 W. Harrison St, Suite #300, Chicago, IL 60612, USA.
Department of Orthopedic Surgery, Rush University Medical Center, 1611 W. Harrison St, Suite #300, Chicago, IL 60612, USA.
Spine J. 2017 Jul;17(7):1026-1032. doi: 10.1016/j.spinee.2017.03.018. Epub 2017 Mar 22.
Cervical disc arthroplasty (CDA) is an emerging technique for the treatment of cervical degenerative disease. Multiple studies have investigated the outcomes of CDA, particularly in comparison with cervical arthrodesis techniques such as anterior cervical discectomy and fusion (ACDF). As many entities have financial interests in CDA implants, it is imperative to consider the influence of conflicts of interest on the results of studies investigating the efficacy of CDA.
This study aimed to determine if there is an association between the presence of conflicts of interest among study authors and the reported outcome of studies involving CDA.
This is a systematic review of clinical CDA publications until October 2016.
The outcome measures are presence of conflicts of interest, level of evidence, and outcome for all included studies.
PubMed and MEDLINE databases were searched for articles presenting clinical, radiographic, and cost outcomes of CDA. Data extracted from each article included title, authors, publication year, level of evidence, prosthesis type, number of operative levels, presence of conflicts of interest, and outcome. Conflicts of interest were determined by the presence of any conflicts for any author within manuscript disclosure sections or through Open Payments reporting. Outcomes of each study were graded as either favorable, unfavorable, or equivocal. The presence of conflicts of interest was tested for an association with the level of evidence and study outcome using Pearson chi-square analysis, Fisher exact test, or logistic regression for categorical variables. The authors report no conflicts of interest directly related to this work, and have not received any funds in support of this work.
A total of 98 articles were included in this analysis. In total, 44.9% (44) of articles had the presence of a conflict of interest, whereas 55.1% (54) of articles did not. Conflicted studies were more likely to present level I evidence and less likely to present level IV evidence than non-conflicted studies (p<.001). Furthermore, conflicted studies were more likely to report favorable outcomes after CDA than non-conflicted studies (90.9% vs. 74.1%, p=.040).
The results of this study suggest that the majority of conflicted and non-conflicted studies report favorable results in patients undergoing CDA. However, conflicted studies were also more likely to report favorable outcomes compared with non-conflicted studies. Individual clinicians must critically review published studies for potential conflicts of interest before incorporating CDA into their practice.
颈椎间盘置换术(CDA)是一种治疗颈椎退行性疾病的新兴技术。多项研究对CDA的疗效进行了调查,特别是与颈椎融合术技术如颈椎前路椎间盘切除融合术(ACDF)进行比较。由于许多机构在CDA植入物方面存在经济利益,因此必须考虑利益冲突对研究CDA疗效的研究结果的影响。
本研究旨在确定研究作者中利益冲突的存在与涉及CDA的研究报告结果之间是否存在关联。
这是一项对截至2016年10月的临床CDA出版物的系统评价。
结果指标为所有纳入研究的利益冲突情况、证据水平和结果。
在PubMed和MEDLINE数据库中搜索呈现CDA临床、影像学和成本结果的文章。从每篇文章中提取的数据包括标题、作者、出版年份、证据水平、假体类型、手术节段数、利益冲突情况和结果。通过稿件披露部分中任何作者存在的任何冲突或通过公开支付报告来确定利益冲突。每项研究的结果分为有利、不利或不明确。使用Pearson卡方分析、Fisher精确检验或分类变量的逻辑回归来检验利益冲突的存在与证据水平和研究结果之间的关联。作者报告没有与这项工作直接相关的利益冲突,也没有收到任何支持这项工作的资金。
本分析共纳入98篇文章。总体而言,44.9%(44篇)的文章存在利益冲突,而55.1%(54篇)的文章不存在利益冲突。与无利益冲突的研究相比,有利益冲突的研究更有可能呈现I级证据,而呈现IV级证据的可能性较小(p<0.001)。此外,与无利益冲突的研究相比,有利益冲突的研究在CDA后更有可能报告有利结果(90.9%对74.1%,p = 0.040)。
本研究结果表明,大多数有利益冲突和无利益冲突的研究在接受CDA的患者中报告了有利结果。然而,与无利益冲突的研究相比,有利益冲突的研究也更有可能报告有利结果。个体临床医生在将CDA纳入其临床实践之前,必须严格审查已发表研究中潜在的利益冲突。