Pain Management Center of Paducah, Paducah, KY, USA.
Pain Physician. 2010 Jul-Aug;13(4):E215-64.
Clinical guidelines are a constructive response to the reality that practicing physicians require assistance in assimilating and applying the exponentially expanding, often contradictory, body of medical knowledge. They attempt to define practices that meet the needs of most patients under most circumstances. Ideally, specific clinical recommendations contained within practice guidelines are systematically developed by expert panels who have access to all the available evidence, have an understanding of the clinical problem, and have clinical experience with the procedure being assessed, as well as knowledge of relevant research methods. The recent development of American Pain Society (APS) guidelines has created substantial controversy because of their perceived lack of objective analysis and recommendations perceived to be biased due to conflicts of interest.
To formally and carefully assess the APS guidelines' evidence synthesis for low back pain for therapeutic interventions using the same methodology utilized by the APS authors. The interventions examined were therapeutic interventions for managing low back pain, including epidural injections, adhesiolysis, facet joint interventions, and spinal cord stimulation.
A literature search by 2 authors was carried out utilizing appropriate databases from 1966 through July 2008. Articles in which conflicts arose were reviewed and mediated by a third author to arrive at a consensus. Selections of manuscripts and methodologic quality assessment was also performed by at least 2 authors utilizing the same criteria applied in the APS guidelines. The guideline reassessment process included the evaluation of individual studies and systematic reviews and their translation into practice recommendations.
The conclusions of APS and our critical assessment based on grading of good, fair, and poor, agreed that there is fair evidence for spinal cord stimulation in post lumbar surgery syndrome, and poor evidence for lumbar intraarticular facet joint injections, lumbar interlaminar epidural injections, caudal epidural steroids for conditions other than disc herniation or radiculitis, sacroiliac joint injections, intradiscal electrothermal therapy, endoscopic adhesiolysis, and intrathecal therapy. However, our assessment of APS guidelines for other interventional techniques, utilizing their own criteria, showed fair evidence for therapeutic lumbar facet joint nerve blocks, caudal epidural injections in disc herniation or radiculitis, percutaneous adhesiolysis in post lumbar surgery syndrome, radiofrequency neurotomy, and transforaminal epidural injections in radiculitis. Also it is illustrated that inclusion of latest literature will change the conclusions, with improved grading - caudal epidural, adhesiolysis, and lumbar facet joint nerve blocks from fair to good or poor to fair. The present critical assessment review illustrates that APS guidelines have utilized multiple studies inappropriately and have excluded appropriate studies. Our integrity assessment shows deep concerns that the APS guidelines illustrating significant methodologic failures which raise concerns about transparency, accountability, consistency, and independence.
The current reassessment, using appropriate methodology, shows evidence similar to APS guidelines for several procedures, but differs extensively from published APS guidelines for multiple other procedures including caudal epidural injections, lumbar facet joint nerve blocks, lumbar radiofrequency neurotomy, and percutaneous adhesiolysis.
临床指南是对以下现实情况的建设性回应:执业医师在吸收和应用数量不断增加且经常相互矛盾的医学知识方面需要得到帮助。它们试图确定在大多数情况下满足大多数患者需求的实践。理想情况下,实践指南中包含的具体临床建议应由专家小组系统地制定,这些专家小组可以获得所有可用证据,了解临床问题,并具有正在评估的程序的临床经验,以及相关研究方法的知识。由于美国疼痛协会 (APS) 指南被认为缺乏客观分析,并且由于利益冲突而被认为存在偏见,因此其建议引起了广泛争议。
使用 APS 作者使用的相同方法,正式而仔细地评估针对治疗性干预的 APS 指南针对下腰痛的证据综合情况。所检查的干预措施包括管理下腰痛的治疗性干预措施,包括硬膜外注射、粘连松解术、关节突关节干预和脊髓刺激。
两位作者进行了文献检索,使用了从 1966 年到 2008 年 7 月的适当数据库。对出现冲突的文章进行了审查,并由第三位作者进行调解,以达成共识。至少有两位作者还进行了手稿选择和方法学质量评估,使用了与 APS 指南相同的标准。指南重新评估过程包括评估个别研究和系统评价,并将其转化为实践建议。
APS 的结论以及我们基于分级为良好、中等和差的关键评估结果一致认为,脊髓刺激在腰椎手术后综合征中有中等证据,而在腰椎关节突关节内注射、腰椎椎间硬膜外注射、尾侧硬膜外类固醇注射用于除椎间盘突出症或神经根炎以外的情况、骶髂关节注射、椎间盘内电热疗法、内窥镜粘连松解术和鞘内治疗方面的证据较差。然而,我们根据自己的标准对 APS 指南的其他介入技术进行评估,结果显示治疗性腰椎关节突关节神经阻滞、椎间盘突出症或神经根炎的尾侧硬膜外注射、腰椎手术后综合征的经皮粘连松解术、射频神经切断术和神经根炎的经椎间孔硬膜外注射有中等证据。此外,还表明纳入最新文献将改变结论,通过改善分级——尾侧硬膜外、粘连松解术和腰椎关节突关节神经阻滞,从中等变为良好或差变为中等。目前的关键评估审查表明,APS 指南不适当地使用了多项研究,并排除了适当的研究。我们的诚信评估表明,APS 指南存在严重的方法学失败,这引起了对透明度、问责制、一致性和独立性的关注。
使用适当方法的当前重新评估显示,几项程序的证据与 APS 指南相似,但与 APS 公布的指南有很大不同,包括尾侧硬膜外注射、腰椎关节突关节神经阻滞、腰椎射频神经切断术和经皮粘连松解术。