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Published on: September 28, 2019
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Reporting Standards and Quality Assurance Methods for Pancreatoduodenectomy in Randomised Controlled Trials: A
Abdullah K Malik1,2, Bishow B Karki3, Balaji Mahendran1,2
1Department of HPB and Transplant Surgery, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE7 7DN, UK.
Journal of Clinical Medicine
|March 28, 2026
Summary
Quality assurance for surgical interventions in randomized controlled trials (RCTs) is poorly reported. This review highlights the need for better standardization and reporting of surgical components in pancreaticoduodenectomy (PD) RCTs.
Area of Science:
- Surgical oncology
- Clinical trial methodology
- Health services research
Background:
- Surgical interventions are complex, posing challenges for standardization and quality assurance in randomized controlled trials (RCTs).
- The Consolidated Standards of Reporting Trials - Non-Pharmacological Treatment (CONSORT-NPT) guidelines aim to improve the reporting quality of surgical RCTs.
- This review examines quality assurance reporting for surgical interventions using pancreatoduodenectomy (PD) RCTs as a case study.
Purpose of the Study:
- To explore and summarize the reporting of quality assurance measures for surgical interventions within RCTs.
- To assess the reporting of quality assurance components in pancreatoduodenectomy (PD) RCTs against CONSORT-NPT recommendations.
Main Methods:
- Searched major databases (PubMed, Medline, Cochrane) for RCTs of PD published between 2020 and 2024.
- Deconstructed PD into 40 components and evaluated RCTs for reporting of these components and quality assurance measures.
- Utilized CONSORT-NPT guidelines for assessment.
Main Results:
- 37 RCTs involving 5659 patients were included; none reported all PD components.
- Four studies reported no PD components; nine described some standardization.
- Only three studies measured adherence to standards, and few specified surgeon or center volumes.
Conclusions:
- Quality assurance measures were inadequately reported in PD RCTs, impacting result interpretation.
- A consensus on core PD components is needed to improve future surgical RCT design and reporting.
- Enhanced reporting of quality assurance in surgical RCTs is crucial for transparency and replicability.
