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A systematic methodological review of non-randomised interventional studies of elective ventral hernia repair: clear definitions and a standardised minimum dataset are needed.
- Source :
-
Hernia : the journal of hernias and abdominal wall surgery [Hernia] 2019 Oct; Vol. 23 (5), pp. 859-872. Date of Electronic Publication: 2019 May 31. - Publication Year :
- 2019
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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.<br />Objective: We aimed to assesses methodological quality of non-randomised interventional studies of VH repair by systematic review.<br />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.<br />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.<br />Conclusion: Currently, non-randomised interventional studies of VH repair are methodologically poor. Clear outcome definitions and a standardised minimum dataset are needed.
Details
- Language :
- English
- ISSN :
- 1248-9204
- Volume :
- 23
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Hernia : the journal of hernias and abdominal wall surgery
- Publication Type :
- Academic Journal
- Accession number :
- 31152271
- Full Text :
- https://doi.org/10.1007/s10029-019-01979-9