# Reporting Standards and Quality Assurance Methods for Pancreatoduodenectomy in Randomised Controlled Trials: A Structured Narrative Review

## TL;DR

This paper reviews how quality assurance is reported in surgical trials for pancreatoduodenectomy, finding significant gaps in standardization and transparency.

## Contribution

The study introduces a structured analysis of quality assurance reporting in surgical RCTs using pancreatoduodenectomy as a case study.

## Key findings

- Only 9 out of 37 studies described standardization measures for surgical procedures.
- Three studies used intra-operative photographs to measure adherence to surgical standards.
- Minimum surgeon and center volumes were specified in just two and six trials, respectively.

## Abstract

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.