Parker, SG;
Halligan, S;
Erotocritou, M;
Wood, CPJ;
Boulton, RW;
Plumb, AAO;
Windsor, ACJ;
(2019)
A systematic methodological review of non-randomised interventional studies of elective ventral hernia repair: clear definitions and a standardised minimum dataset are needed.
Hernia
10.1007/s10029-019-01979-9.
(In press).
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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. // 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. // CONCLUSION: Currently, non-randomised interventional studies of VH repair are methodologically poor. Clear outcome definitions and a standardised minimum dataset are needed.
| Type: | Article |
|---|---|
| Title: | A systematic methodological review of non-randomised interventional studies of elective ventral hernia repair: clear definitions and a standardised minimum dataset are needed |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1007/s10029-019-01979-9 |
| Publisher version: | https://doi.org/10.1007/s10029-019-01979-9 |
| Language: | English |
| Additional information: | © The Author(s) 2019. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/ licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
| Keywords: | Hernia, Methodology, Standardisation, Studies, Ventral |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Department of Imaging UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Experimental and Translational Medicine |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10076208 |
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