South West Sydney Clinical School, University of New South Wales; and Whitlam Orthopaedic Research Centre, Liverpool Hospital, Liverpool, New South Wales, Australia.
Ann Surg. 2013 Dec;258(6):872-8. doi: 10.1097/SLA.0b013e31829664b9.
We performed a systematic review assessing the reporting quality of trials of surgical interventions, and explored associated trial level variables.
Randomized controlled trials (RCTs) provide clinicians with the best evidence for the effects of interventions, but may not be reported with necessary detail.
In May 2009, 3 databases (MEDLINE, EMBASE, and CENTRAL) were searched for RCTs that assessed a surgical intervention using a comprehensive electronic strategy developed by the Cochrane Collaboration. The Consolidated Standards of Reporting Trials (CONSORT) checklist was used as a measure of reporting quality. An overall CONSORT score was calculated and expressed as a proportion. This was supplemented with domains related to external validity. We also collected data on characteristics hypothesized to improve reporting quality, and exploratory regression was performed to determine associations.
One hundred fifty recently published RCTs were included. The most commonly represented surgical subspecialties were general (29%), orthopedic (23%), and cardiothoracic (13%). Most (65%) were published in subspecialty surgical journals. Overall reporting quality was low, with only 55% of CONSORT items addressed. Less than half of trials described adequate methods for sample size calculation (45%), random sequence generation (43%), allocation concealment (45%), and blinding (37%). The strongest associations with reporting quality were adequate methods related to methodological domains, an author with an epidemiology/statistics degree, and a longer report length.
There remains much room for improvement for the reporting of surgical intervention trials. Authors and journal editors should apply existing reporting guidelines, and guidelines specific to the reporting of surgical interventions should be developed.
我们进行了一项系统评价，评估了外科干预试验的报告质量，并探讨了相关的试验水平变量。
随机对照试验（RCT）为临床医生提供了干预效果的最佳证据，但可能没有必要的细节报告。
2009 年 5 月，我们使用由 Cochrane 协作组织开发的全面电子策略，在 3 个数据库（MEDLINE、EMBASE 和 CENTRAL）中搜索评估外科干预的 RCT。采用 CONSORT 清单作为报告质量的衡量标准。计算了总体 CONSORT 评分，并表示为比例。这与与外部有效性相关的领域相结合。我们还收集了假设能提高报告质量的特征数据，并进行了探索性回归以确定关联。
纳入了 150 项最近发表的 RCT。最常见的外科亚专科是普通外科（29%）、骨科（23%）和心胸外科（13%）。大多数（65%）发表在专业外科期刊上。整体报告质量较低，仅 55%的 CONSORT 项目得到了处理。不到一半的试验描述了足够的样本量计算方法（45%）、随机序列生成（43%）、分配隐藏（45%）和盲法（37%）。与报告质量最密切相关的是方法学领域的适当方法、具有流行病学/统计学学位的作者以及更长的报告长度。
外科干预试验的报告仍有很大的改进空间。作者和期刊编辑应应用现有的报告指南，并应制定专门针对外科干预报告的指南。
