HPB P24 Quality assurance within multicentre randomised controlled trials of surgical interventions for pancreatic cancer: a systematic review

Abstract

Abstract Background Pancreatic cancer surgery is a complex intervention, with numerous studies exploring variations in approach to curative resection with the aim of improving outcomes. Multicentre randomised controlled trials (RCTs) represent the gold standard for evaluating these technical modifications. However, variations in how surgical intervention are delivered across trial sites and individual surgeons can influence results. Surgical quality assurance mechanisms within trial designs attempt to mitigate this by ensuring standardised, high-quality technique and reducing heterogeneity of procedures. This systematic review aimed to identify approaches to quality assurance within multicentre randomised controlled trials of surgical interventions for pancreatic cancer. Methods A systematic review was performed by searching MEDLINE and Embase databases between 1st January 2000 and 18th December 2022. Articles were deemed eligible for inclusion if they were a multicentre RCT and evaluated a surgical intervention, technique modification or variation in approach to surgical resection for pancreatic cancer. Data was extracted from included studies using a semi-structured form, with consideration of four prospectively defined quality assurance domains: i) surgical intervention and co-interventions description, ii) surgical technique standardisation, iii) performance monitoring methods, iv) surgeon/ unit credentialing methods. Results A total of 1970 studies were identified from the initial search, of which 44 trials were deemed eligible for inclusion. Thirty-six RCTs (81.8%) provided description of the intervention and/or co-intervention. Attempts to standardise technique were described in 33 RCTs (75.0%). However, only 4 trials (9.1%) deconstructed the intervention into its constituent components. Twelve studies (27.3%) described methods used to monitor performance and adherence to the intervention. The most common approaches used were intra-operative photographs (n=7; 15.9%), surgeon self-declaration (n=3; 6.8%), and pathological specimen review (n=2; 4.5%). Ten studies (22.7%) used credentialing methods based on unit entry criteria. Conclusions This study provides important data on the utilisation of methods of surgical quality assurance within pancreatic RCTs. With the exception of intervention description, compliance to the remaining domains of quality assurance was low. This may compromise the extent to which observed differences in clinical outcomes are due to the technique being evaluated within these trials. Confidence in the results of future RCTs would be improved by enhanced quality assurance across the four domains described.