Exploring the need for reconsideration of trial design in perioperative outcomes research: a narrative review

Kehlet, Henrik; Lobo, Dileep N.

Abstract

“Enhanced recovery after surgery” is a multimodal effort to control perioperative pathophysiology and improve outcome. However, despite advances in perioperative care, postoperative complications and the need for hospitalisation and prolonged recovery continue to be challenging. This is further complicated by procedure-specific and patient-associated risk factors, given the increase in the number of elderly and frail patients with multiple comorbidities undergoing surgery. This paper is a critical assessment of current methodology for trials in perioperative medicine. We make a plea to reconsider the design of future interventional trials to improve surgical outcome, based upon studies of potentially effective interventions, but often without improvements in recovery. The complexity of perioperative pathophysiology necessitates a procedure- and patient-specific approach whenever outcome is assessed or interventions are planned. With improved understanding of perioperative pathophysiology, the way to improve outcomes looks promising, provided that knowledge and established enhanced recovery programmes are integrated in trial design.

• Journal Article Type: Review
• Acceptance Date: Feb 16, 2024
• Online Publication Date: Feb 29, 2024
• Publication Date: 2024-04
• Deposit Date: Feb 16, 2024
• Publicly Available Date: Feb 29, 2024
• Journal: eClinicalMedicine
• Electronic ISSN: 2589-5370
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 70
• Article Number: 102510
• DOI: https://doi.org/10.1016/j.eclinm.2024.102510
• Keywords: Perioperative medicine; Enhanced recovery after surgery; Trial design; Interventions; Outcomes
• Public URL: https://nottingham-repository.worktribe.com/output/31450953
• Publisher URL: https://www.thelancet.com/retrieve/pii/S2589537024000890