Core Outcome Sets for Pediatric Perioperative Research: An International Stakeholder Engagement Exercise and Consensus Report from the Pediatric Perioperative Outcomes Group.

BACKGROUND: Identifying the outcomes that matter in clinical research is important, especially those that matter to patients and their parents/guardians. Consistency in outcome reporting enables meaningful assessments of interventions and facilitates comparison of results across trials. The aim of this study was to develop core outcome sets for pediatric perioperative research.

METHODS: The authors determined core outcome sets through extensive stakeholder engagement, following a stepwise process as recommended by the Core Outcome Measures in Effectiveness Trials (COMET) initiative. They surveyed patients, parents/guardians, and healthcare providers to elicit views on the importance of perioperative outcomes. These results informed a subsequent Delphi process of expert stakeholder representatives. Final core outcome sets were agreed to after virtual face-to-face meetings of the investigators.

RESULTS: A total of 1,178 total subjects were included in the international stakeholder survey: 81 patients ages 8 to 12 yr, 99 patients ages 13 to 17 yr, 587 parents/guardians, and 411 healthcare providers (128 nurses, 147 anesthesiologists, and 136 surgeons). Subjects were recruited in Australia, Canada, China, Colombia, the Netherlands, New Zealand, South Africa, Switzerland, and the United States. Sixty-seven expert stakeholders completed a two-round Delphi, including 7 patient family representatives, 9 surgeons, 7 nurses, and 44 anesthesiologists. Proposed core outcome sets were voted on and unanimously agreed to after the virtual face-to-face meetings for the following populations: neonates, infants, children ages 1 to 12 yr, and adolescents ages 13 to 17 yr. Core outcomes for all populations included cardiovascular or respiratory adverse events, pain, assessment of pain relief, and unplanned medical attention. Quality of recovery was included in all but the neonate population, while return to normal function was also included in the adolescent population.

CONCLUSIONS: The authors identified perioperative core outcome sets for four age-based pediatric populations. Researchers should include these outcomes in their studies whenever appropriate, in addition to the outcomes specific to their research question.