The Abdominal Wall Unit UCLH, GI Services Department, University College London Hospital, 235 Euston Road, London, NW1 2BU, UK.
UCL Centre for Medical Imaging, 2nd Floor Charles Bell House, 43-45 Foley Street, London, W1W 7TS, UK.
Hernia. 2019 Oct;23(5):859-872. doi: 10.1007/s10029-019-01979-9. Epub 2019 May 31.
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.
We aimed to assesses methodological quality of non-randomised interventional studies of VH repair by systematic review.
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.
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.
Currently, non-randomised interventional studies of VH repair are methodologically poor. Clear outcome definitions and a standardised minimum dataset are needed.
腹疝（VHs）在手术后经常复发，随后的修复尝试尤其具有挑战性。需要进行严格的研究来降低复发率，但此类研究必须设计合理，并报告具有代表性和全面的结果。
通过系统评价评估 VH 修复的非随机干预研究的方法学质量。
我们检索了 1995 年 1 月至 2017 年 12 月期间关于 VH 修复干预的非随机研究，每个前瞻性研究都与使用预设标准的相应回顾性研究相匹配，以提供具有可比性的组。我们通过将现有已发表工具中的相关项目相结合，应用了一种用于疝试验的定制方法学工具。评估了研究介绍和原理、设计、参与者纳入标准、报告的结果和统计方法。
共确定了 50 项研究（17608 名患者）：25 项前瞻性研究和 25 项回顾性研究。总体而言，前瞻性研究的方法学质量评分略高于回顾性研究，中位数分别为 17（IQR：14-18）和 15（IQR 12-18）。在所调查的子类别中，前瞻性研究在其“介绍”、“研究设计”和“参与者”方面的得分更高。令人惊讶的是，没有一项研究表示已事先编写了方案。只有 18 项（36%）研究定义了主要结局，只有 2 项（4%）研究描述了计算效力。没有研究引用 VH 复发的标准化定义，并且复发的检测方法差异很大。方法学质量并未随发表年份或期刊影响因子的增加而提高。
目前，VH 修复的非随机干预研究方法学较差。需要明确的结局定义和标准化的最小数据集。
