Background

Many techniques and devices used to detect and prevent cancer involve invasive procedures (e.g. endoscopic procedures). Innovation in invasive procedures/devices are common and important to improve patient outcomes. Rigorous evaluation of new invasive techniques/devices is, however, lacking. Reporting of outcomes in early phase studies is unstandardized. Mandated outcome reporting throughout the innovation lifecycle may prevent surgeons from repeating mistakes and can avoid patient harm. Detailed outcome reporting guidance is, however, lacking. The development of a core outcome set (COS), an agreed minimum set of outcomes to report, promotes the safe and efficient evaluation of all new invasive procedures/devices and can address these problems.

Method

The COS was developed according to established guidance (COMET, COS-STAD). Outcomes identified from published studies, NHS policies, regulatory documentation and surgeon-innovator and patient interviews informed an international Delphi consensus survey. Patients and professionals rated the importance of each item/outcome across two survey rounds. A multi-stakeholder consensus meeting agreed the final COS.

Results

7,666 verbatim outcomes were categorised into 32 domains. Innovation-specific domains included: procedure completion success/failure, modifications, unanticipated advantages and disadvantages, surgeon/operator experience, patient experience and resource use specific to the innovative procedure/device. 148 professionals and 103 patients across 15 international regions completed both survey rounds. A consensus meeting convened 30 panel members, including patient representatives and professionals representing a wide range of specialties and professions. Anonymised voting resulted in the inclusion and consolidation of 8 outcome domains to be included in the final COS.

Conclusion

The COS will promote the safe and efficient evaluation of new invasive procedures/devices by reducing outcome reporting bias and allowing real-time data synthesis to improve detection of emerging signals of promising or harmful innovations.

Impact statement

A Core Outcome Set for all studies of early phase surgical interventions promotes the standardised measurement and reporting of outcomes, ultimately increasing evidence-based introduction of new invasive procedures and devices to minimise patient harm and research waste.