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Lookup NU author(s): Abdullah MalikORCiD, Dr Balaji Mahendran, John Moir, Dr Deborah Stocken
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2026 by the authors. 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.
Author(s): Malik AK, Karki BB, Mahendran B, Moir JAG, Shrikhande SV, Smith AM, Stocken DD, Blencowe NS, Pathak S
Publication type: Review
Publication status: Published
Journal: Journal of Clinical Medicine
Year: 2026
Volume: 15
Issue: 6
Online publication date: 23/03/2026
Acceptance date: 20/03/2026
ISSN (electronic): 2077-0383
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
URL: https://doi.org/10.3390/jcm15062455
DOI: 10.3390/jcm15062455
Data Access Statement: No new data were created or analysed in this study.
