Continuity of outcome assessment throughout the lifecycle of surgical research: mapping core outcome domains measured in early phase and late phase studies

Background
Consistent outcome assessment in surgical research, from early phase studies (during introduction and refinement of new procedures) to late phase studies (to establish comparative effectiveness) needs improvement to ensure efficient and safe surgical care. This study explored the potential continuity of outcome domain assessment throughout the evaluation lifecycle of surgical interventions.

Methods
Core outcome sets (COS) for late phase studies of surgical interventions were identified through COMET database searches. Core outcomes/outcome domains were extracted and mapped to core domains of a COS developed specifically for evaluating surgical innovation (COHESIVE COS). Outcomes/domains were categorised as “definite match” (clear similarity), “possible match” (potential similarity) and “no match” (no similarity) COHESIVE domain based on similarity in wording or meaning.

Results
A total of 54 COS studies were included, yielding 573 core outcomes/domains. Most late phase core outcomes/domains (N = 519, 91%) showed clear or possible similarity. All late phase COS studies recommended measurement of COHESIVE domains ‘Intended benefits’ and ‘Expected and unexpected disadvantages’. Some late phase outcomes/domains also showed similarity with early phase COHESIVE domains, including ‘Problems with the device working’, ‘Patients’ experience’ and ‘Operators’/surgeons’ experience’. A minority of late phase outcomes/domains showed no similarity with COHESIVE domains (n = 54, 9%).

Conclusion
High similarity between outcome domains recommended in early and late phase evaluations of surgical interventions demonstrates continuity of outcome domain assessment throughout the surgical innovation lifecycle is possible. Harmonising outcome measurement throughout the research pathway can streamline evaluation, enhancing access to beneficial treatment and improving early detection of harms.