A systematic methodological review of non-randomised interventional studies of elective ventral hernia repair: clear definitions and a standardised minimum dataset are needed

Parker, Samuel G.; Halligan, Steve; Erotocritou, Marios; Wood, Christopher P.; Boulton, Richard; Plumb, Andrew; Windsor, Alastair; Mallett, Susan

doi:10.1007/s10029-019-01979-9

Cited by 15 publications

(11 citation statements)

References 67 publications

(146 reference statements)

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“…Despite this, the majority of studies fail adequately to capture or report patient-centred outcomes such as quality of life and pain. Parker and colleagues reported that four studies out of 31 employed a PRO as a primary endpoint in RCTs assessing ventral hernia repair 6 . To ensure outcome reporting reflects the goals and aims of incisional hernia repair, it is essential that PROs are appropriately defined, captured and reported.…”

Section: Introductionmentioning

confidence: 99%

A systematic review of outcome reporting in incisional hernia surgery

et al. 2021

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Background The incidence of incisional hernia is up to 20 per cent after abdominal surgery. The management of patients with incisional hernia can be complex with an array of techniques and meshes available. Ensuring consistency in reporting outcomes across studies on incisional hernia is important and will enable appropriate interpretation, comparison and data synthesis across a range of clinical and operative treatment strategies. Methods Literature searches were performed in MEDLINE and EMBASE (from 1 January 2010 to 31 December 2019) and the Cochrane Central Register of Controlled Trials. All studies documenting clinical and patient-reported outcomes for incisional hernia were included. Results In total, 1340 studies were screened, of which 92 were included, reporting outcomes on 12 292 patients undergoing incisional hernia repair. Eight broad-based outcome domains were identified, including patient and clinical demographics, hernia-related symptoms, hernia morphology, recurrent incisional hernia, operative variables, postoperative variables, follow-up and patient-reported outcomes. Clinical outcomes such as hernia recurrence rates were reported in 80 studies (87 per cent). A total of nine different definitions for detecting hernia recurrence were identified. Patient-reported outcomes were reported in 31 studies (34 per cent), with 18 different assessment measures used. Conclusions This review demonstrates the significant heterogeneity in outcome reporting in incisional hernia studies, with significant variation in outcome assessment and definitions. This is coupled with significant under-reporting of patient-reported outcomes.

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Section: Introductionmentioning

confidence: 99%

A systematic review of outcome reporting in incisional hernia surgery

et al. 2021

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“…There were differences in the detection of recurrence methods employed (clinical versus radiological (ultrasound versus cross-sectional imaging e.g. computed tomography) versus combination), although five studies failed to describe the detection method used [ 11 , 13 , 16 , 18 , 22 ]. Several studies included a mixture of mesh placements within their cohorts making it difficult to draw meaningful conclusions from the results.…”

Section: Discussionmentioning

confidence: 99%

“…Descriptions of procedures performed were collected including surgical technique, number of procedures previously performed by the surgeon and monitoring of technique. Degree of contamination (clean contaminated, contaminated, and dirty surgery) was defined according to the Centre for Disease Control Surgical Wounds Classification [ 11 ] and location of bioabsorbable mesh placement was also evaluated: intraperitoneal, preperitoneal, retro-muscular, retro-rectus, inlay, or onlay [ 12 , 13 ]. Urgency of surgery (i.e.…”

Section: Methodsmentioning

confidence: 99%

Bioabsorbable mesh use in midline abdominal wall prophylaxis and repair achieving fascial closure: a cross-sectional review of stage of innovation

Kamarajah

Smart

Daniels

et al. 2020

Hernia

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Background Achieving stable closure of complex or contaminated abdominal wall incisions remains challenging. This study aimed to characterise the stage of innovation for bioabsorbable mesh devices used during both midline closure prophylaxis and complex abdominal wall reconstruction and to evaluate the quality of current evidence. Methods A systematic review of published and ongoing studies was performed until 31st December 2019. Inclusion criteria were studies where bioabsorbable mesh was used to support fascial closure either prophylactically after midline laparotomy or for repair of incisional hernia with midline incision. Exclusion criteria were: (1) study design was a systematic review, meta-analysis, letter, review, comment, or conference abstract; (2) included less than p patients; (3) only evaluated biological, synthetic or composite meshes. The primary outcome measure was the IDEAL framework stage of innovation. The key secondary outcome measure was the risk of bias in non-randomised studies of interventions (ROBINS-I) criteria for study quality. Results Twelve studies including 1287 patients were included. Three studies considered mesh prophylaxis and nine studies considered hernia repair. There were only two published studies of IDEAL 2B. The remainder was IDEAL 2A studies. The quality of the evidence was categorised as having a risk of bias of a moderate, serious or critical level in nine of the twelve included studies using the ROBINS-I tool. Conclusion The evidence base for bioabsorbable mesh is limited. Better reporting and quality control of surgical techniques are needed. Although new trial results over the next decade will improve the evidence base, more trials in emergency and contaminated settings are required to establish the limits of indication.

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“…Matching is also sometimes used. In the methodological study of non-randomized interventional studies of elective ventral hernia repair, Parker et al matched prospective studies with retrospective studies and compared reporting standards [74]. Some other methodological studies use statistical adjustments.…”

Section: Some Frequently Asked Questions About Methodsological Studiesmentioning

confidence: 99%

A tutorial on methodological studies: the what, when, how and why

Mbuagbaw

Lawson

Puljak

et al. 2020

BMC Med Res Methodol

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Background Methodological studies – studies that evaluate the design, analysis or reporting of other research-related reports – play an important role in health research. They help to highlight issues in the conduct of research with the aim of improving health research methodology, and ultimately reducing research waste. Main body We provide an overview of some of the key aspects of methodological studies such as what they are, and when, how and why they are done. We adopt a “frequently asked questions” format to facilitate reading this paper and provide multiple examples to help guide researchers interested in conducting methodological studies. Some of the topics addressed include: is it necessary to publish a study protocol? How to select relevant research reports and databases for a methodological study? What approaches to data extraction and statistical analysis should be considered when conducting a methodological study? What are potential threats to validity and is there a way to appraise the quality of methodological studies? Conclusion Appropriate reflection and application of basic principles of epidemiology and biostatistics are required in the design and analysis of methodological studies. This paper provides an introduction for further discussion about the conduct of methodological studies.

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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

Cited by 15 publications

References 67 publications

A systematic review of outcome reporting in incisional hernia surgery

A systematic review of outcome reporting in incisional hernia surgery

Bioabsorbable mesh use in midline abdominal wall prophylaxis and repair achieving fascial closure: a cross-sectional review of stage of innovation

A tutorial on methodological studies: the what, when, how and why

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