A systematic methodological review of non-randomised interventional studies of elective ventral hernia repair: Clear definitions and standardised datasets are needed

Sam G Parker, Susan Mallett, Steve Halligan, chris PJ Wood, Nick Simson, Andrew Plumb, Alastair CJ Windsor

Research output: Contribution to journalArticlepeer-review

Abstract

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 assessment 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 score 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.
Conclusion
Currently, non-randomised interventional studies of VH repair are methodologically poor. Clear definitions and standardised datasets are needed.
Original languageEnglish
JournalHernia: the journal of hernias and abdominal wall surgery
Publication statusAccepted/In press - 12 May 2019

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