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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

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). Green open access

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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 > Provost and Vice Provost Offices
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 > Metabolism and Experi Therapeutics
URI: https://discovery.ucl.ac.uk/id/eprint/10076208
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