背景:腹侧疝(VHs)经常在手术修复后复发,随后的修复尝试尤其具有挑战性。需要进行严格的研究以减少复发,但此类研究必须精心设计并报告代表性和全面的结果。
目的:我们旨在通过系统评价评估VH修复的非随机介入研究的方法学质量。
方法:我们在索引文献中搜索了VH修复干预的非随机研究,1995年1月至2017年12月。每个前瞻性研究与相应的回顾性研究结合使用预先指定的标准,以提供匹配的,可比群体。我们通过结合现有已发布工具的相关项目,将定制的方法学工具用于疝气试验。研究简介和基本原理,设计,参与者纳入标准,报告的结果,并采用统计学方法进行评估。
结果:确定了50项研究(17,608例患者):25项前瞻性研究和25项回顾性研究。总的来说,前瞻性研究的方法学质量略高于回顾性研究,中位数得分17(IQR:14-18)与15(IQR12-18),分别。对于调查的子类别,前瞻性研究获得了更高的中位数分数,\'介绍\',\'研究设计\'和\'参与者\'。令人惊讶的是,没有研究表明事先编写了方案.只有18项(36%)研究定义了主要结果,只有2项研究(4%)描述了功率计算。没有研究引用VH复发的标准化定义和复发的检测方法差异很大。方法质量没有随着出版年份或期刊影响因子的增加而提高。
结论:目前,VH修复的非随机介入研究在方法学上较差。需要明确的结果定义和标准化的最小数据集。
BACKGROUND: Ventral hernias (VHs) often recur after surgical repair and subsequent attempts at repair are especially challenging. Rigorous research to reduce recurrence is required but such
studies must be well-designed and report representative and comprehensive outcomes.
OBJECTIVE: We aimed to assesses methodological quality of non-randomised interventional studies of VH repair by systematic
review.
METHODS: We searched the indexed literature for non-randomised
studies of interventions for VH repair, January 1995 to December 2017 inclusive. Each prospective study was coupled with a corresponding retrospective study using pre-specified criteria to provide matched, comparable groups. We applied a bespoke methodological tool for hernia trials by combining relevant items from existing published tools. Study introduction and rationale, design, participant inclusion criteria, reported outcomes, and statistical methods were assessed.
RESULTS: Fifty studies (17,608 patients) were identified: 25 prospective and 25 retrospective. Overall, prospective
studies scored marginally higher than retrospective
studies for methodological quality, median score 17 (IQR: 14-18) versus 15 (IQR 12-18), respectively. For the sub-categories investigated, prospective studies achieved higher median scores for their, \'introduction\', \'study design\' and \'participants\'. Surprisingly, no study stated that a protocol had been written in advance. Only 18 (36%)
studies defined a primary outcome, and only 2
studies (4%) described a power calculation. No study referenced a standardised definition for VH recurrence and detection methods for recurrence varied widely. Methodological quality did not improve with publication year or increasing journal impact factor.
CONCLUSIONS: Currently, non-randomised interventional studies of VH repair are methodologically poor. Clear outcome definitions and a standardised minimum dataset are needed.