Department of Orthopedic Surgery, Orthopedic Research Center Amsterdam, Academic Medical Center, Ontario, Canada.
Spine (Phila Pa 1976). 2013 May 1;38(10):857-64. doi: 10.1097/BRS.0b013e31827ecb1c.
A systematic review of published trials in orthopedic spine literature.
To determine the quality of reporting in open spine surgery randomized controlled trials (RCTs) between 2005 and 2010 with special focus on the reporting of surgical skill or expertise.
In technically demanding procedures such as spine surgery, a surgeon's skill and expertise is expected to play an important role in the outcome of the procedure. To appraise the reported treatment effect of spine surgery related RCTs adequately, any potential skill or experience bias must be reported.
MEDLINE, the Cochrane Library, and EMBASE were systematically searched for open spine surgery RCTs published between January 1, 2005, and December 31, 2010. Percutaneous techniques were excluded. The quality of reporting of all eligible studies was determined using the checklist to evaluate a report of a nonpharmacological trial. The reporting of surgeons' skill and experience was scored additionally. Subsequently, all authors were surveyed to determine if any information on methodological safeguards was omitted from their reports. All data were analyzed in 2-year time frames.
Ninety-nine RCTs were included. Ten studies (10%) described surgical skill or experience, mostly as a description of the learning curve. The majority of publications were unclear about "concealment of treatment allocation" (77%), "blinding of participants" (68%), "blinding of outcome assessors" (77%), and "adhering to the intention-to-treat principle" (67%). Of the 99 surveys, we received 22 (22%) completed questionnaires. In these questionnaires, information about essential methodological safeguards was often available, although not reported in the primary publication.
This study shows that in open spine surgery RCTs information on skill and experience is scarcely reported. Authors often fail to report essential methodological safeguards. These studies may therefore be prone to expertise bias.
对骨科脊柱文献中已发表试验进行的系统评价。
确定 2005 年至 2010 年间开放性脊柱手术随机对照试验（RCT）的报告质量，特别关注手术技能或专业知识的报告情况。
在技术要求较高的手术中，如脊柱手术，外科医生的技能和专业知识预计将在手术结果中发挥重要作用。为了充分评估与脊柱手术相关的 RCT 的报告治疗效果，必须报告任何潜在的技能或经验偏倚。
系统检索了 2005 年 1 月 1 日至 2010 年 12 月 31 日期间发表的开放性脊柱手术 RCT 的 MEDLINE、Cochrane 图书馆和 EMBASE。排除了经皮技术。使用评估非药物试验报告的清单确定所有合格研究的报告质量。此外，对外科医生的技能和经验进行评分。随后，对所有作者进行了调查，以确定他们的报告中是否遗漏了任何关于方法学保障的信息。所有数据均在 2 年的时间框架内进行分析。
共纳入 99 项 RCT。有 10 项研究（10%）描述了手术技能或经验，主要是描述学习曲线。大多数出版物对“治疗分配的隐藏”（77%）、“参与者的盲法”（68%）、“结果评估者的盲法”（77%）和“坚持意向治疗原则”（67%）不清楚。在 99 份调查中，我们收到了 22 份（22%）完成的问卷。在这些问卷中，虽然没有在主要出版物中报告，但经常可以获得有关基本方法学保障的信息。
本研究表明，在开放性脊柱手术 RCT 中，有关技能和经验的信息很少被报告。作者经常未能报告基本的方法学保障措施。因此，这些研究可能容易受到专业知识偏倚的影响。
