Reporting Standards and Quality Assurance Methods for Pancreatoduodenectomy in Randomised Controlled Trials: A Structured Narrative Review
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Le résumé fourni par la source
Background: Surgical interventions are complex and comprise multiple components, creating difficulties when considering how they might be described, standardised, and monitored (i.e., quality assurance) within randomised controlled trials (RCTs). Consolidated Standards of Reporting Trials – Non-Pharmacological Treatment (CONSORT-NPT) provides specific recommendations to improve the quality, transparency, and replicability of RCTs involving a surgical intervention. This structured narrative review explores and summarizes the reporting of quality assurance measures for surgical interventions in RCTs, using pancreatoduodenectomy (PD) as an exploratory case study. Methods: Searches for RCTs of PD were undertaken in PubMed, Medline, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews from 2020 to 2024. Pancreatoduodenectomy (PD) was deconstructed into its constituent components (n = 40), and selected RCTs were scrutinised to explore reporting of quality assurance measures against the deconstructed components as described in CONSORT-NPT. Results: Of 189 screened articles, 37 RCTs were included, reporting on 5659 patients across 16 countries. No studies described all components of PD, and four did not report any components at all. Nine studies described some form of standardisation, and three measured adherence to standards, using intra-operative photographs. Minimum surgeon and centre volumes were specified in two and six trials, respectively. Conclusions: Quality assurance measures were poorly reported in selected RCTs involving PD, creating uncertainty in interpreting results. To enhance the design of future RCTs, a wider consensus regarding the core components of a PD is required. This will facilitate subsequent consideration of how these might need to be reported in future pancreatic surgical RCTs.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Reporting Standards and Quality Assurance Methods for Pancreatoduodenectomy in Randomised Controlled Trials: A Structured Narrative Review
- Date Crossref
- 23/03/2026
- Éditeur
- MDPI AG
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Newcastle upon Tyne Hospitals NHS Foundation Trust pays non établi dans la noticeÉtablissement de santé
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Newcastle University Newcastle Fibrosis Research Group pays non établi dans la noticeUniversité ou école supérieure
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Leeds Teaching Hospitals NHS Trust pays non établi dans la noticeÉtablissement de santé
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Tata Memorial Hospital Department of HPB Surgery pays non établi dans la noticeÉtablissement de santé
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University of Leeds Leeds Institute for Clinical Trials Research pays non établi dans la noticeUniversité ou école supérieure
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At Bristol pays non établi dans la noticeOrganisation à but non lucratif
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NIHR Bristol Biomedical Research Centre pays non établi dans la noticeOrganisme public
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Freeman Hospital Department of HPB and Transplant Surgery pays non établi dans la noticeÉtablissement de santé
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St James’s Hospital Department of Pancreatobiliary Surgery pays non établi dans la noticeÉtablissement de santé
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Centre for Surgical Research pays non établi dans la noticeInstitution
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Leeds Institute for Emergency General Surgery pays non établi dans la noticeStructure de recherche
Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Fibrosis Research Group — Newcastle University et Leeds Teaching Hospitals NHS Trust, avec 8 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.