Quality assurance of surgical interventions for pancreatic cancer: systematic review of multicentre randomized clinical trials.

[BACKGROUND] Surgical interventions for pancreatic cancer are complex due to numerous interacting components. This complexity can make the design and conduct of randomized clinical trials (RCTs) challenging due to variations in how surgical interventions are delivered across centres and surgeons. Quality assurance (QA) methods, such as those described within the CONSORT recommendations for non-pharmacological interventions (CONSORT-NPT), attempt to mitigate this. The extent of the adoption of such QA methods in RCTs evaluating surgical interventions for pancreatic cancer is unclear.

[METHODS] A systematic review was conducted on multicentre RCTs evaluating surgical interventions for pancreatic cancer. Data were extracted within four QA domains described within the CONSORT-NPT checklist: surgical intervention description, standardization, adherence, and clinician and unit expertise.

[RESULTS] Of 2374 studies identified, 45 were eligible for inclusion in this review. Thirty-eight RCTs (84%) described the intervention and 20 (44%) attempted to standardize techniques. Information about permitted flexibility in surgical interventions was described in 14 RCTs (31%). Fourteen studies (31%) described methods used to measure adherence to the intervention, with intra-operative photographs/videos (ten studies) being the most common. Nineteen studies (42%) detailed surgeon or unit expertise, and six (13%) used credentialing criteria.

[CONCLUSION] Although most RCTs described the intervention, reporting on standardization, adherence, and expertise was often lacking. This may affect RCT results and compromise the extent to which observed differences in clinical outcomes are due to the actual intervention being delivered. More rigorous application and reporting of QA measures are needed to improve confidence in the results of future RCTs, which may, in turn, enhance implementation in clinical practice.