Benefit and harm outcomes of early phase studies

Co-led by Dr Kerry Avery and Miss Shelly Potter

New innovative surgical devices and procedures are currently not subject to the same testing and regulation as medicines. This is because early phase studies are haphazard, may be poorly designed and inconsistently reported, and there is no current consensus on how to select, measure and report outcomes at each stage of innovation. This limits evidence syntheses, risking outcome reporting bias, and may lead to over-optimistic assessment of new interventions and under reporting of adverse effects (harms).

Our aim in this workstream is to investigate whether it is possible to develop a Core Outcome Set to use in early phase studies of trials of invasive procedures and/or devices. We are doing this through the Core Outcomes for Early Phase Surgical Innovation and Devices (COHESIVE) Study. A Core Outcome Set is a scientifically agreed minimum list of which outcomes should be measured and reported in all studies of a specific condition.

We will further our collaboration with COMET (Core Outcome Measures for Effectiveness Trials) initiative and collaborate with surgeon innovators in many different specialities to do this work. We will apply this expertise to develop a system for standardised real-time reporting of outcomes for the monitoring of innovative invasive procedures.