Outcome assessment continuity in early and late phase surgical research

Early evaluation of innovative (new) surgical procedures and devices provides the evidence we need to support their safe introduction into clinical practice. These early phase studies are also important for understanding whether a new surgical procedure/device is ready for further evaluation in larger ‘late phase’ clinical studies.

Standards for measuring outcomes, such as benefits and harms, during early phase surgical research aren’t well-established. We have a limited understanding of whether the outcomes measures in early phase and late phase studies are similar or different. This could potentially lead to bias and inconsistency in how outcomes of new surgical procedures or medical devices are measured and reported over time.

Our team has previously undertaken a series of studies to address this problem. For example:

• We examined existing practices for reporting outcomes in early phase studies of surgical innovation
• We examined existing practices for reporting outcomes in case-studies of innovative devices
• We identified 8 core outcome domains to be measured and reported in all early phase studies to evaluate new surgical procedures and devices in the early phases of their development (The COHESIVE study)

Project aims

This study explored the potential for improving continuity in how outcomes of surgical innovations undergoing early and late phase evaluation are assessed.

What we did

We reviewed core outcome sets (COSs) relevant to later phase studies of invasive surgical procedures/devices.

Core outcome sets are agreed, standardised outcome sets that should be measured and reported in all studies in a specific area of health or healthcare, as a minimum.

Core outcome sets help to ensure researchers measure outcomes that are important to patients, clinicians and others involved in healthcare evaluation. They also help to make it possible to combine and compare the results from multiple studies.

We mapped our results to the COHESIVE COS, an eight-item COS developed to evaluate early phase surgical interventions. Our work:

• Showed high similarity/continuity between late-phase COS and the COHESIVE COS
• Highlighted important outcome domains that should be measured at all stages of the evaluation process
• Demonstrated the potential for consistent outcome assessment at all stages of the evaluation process

What next

We will use findings from this study to promote and embed the use of the COHESIVE COS throughout the evaluation life cycle of surgical innovations.