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: We determined core outcome sets through extensive stakeholder engagement, following a stepwise process as recommended by the COMET initiative. We 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 following virtual face-to-face meetings of the investigators.
Results: 1,178 total subjects were included in the international stakeholder survey: 81 patients ages 8-12 years, 99 patients ages 13-17 years, 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 USA. 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 following the virtual face-to-face meetings for the following populations: neonates, infants, children ages 1-12 years, and adolescents ages 13-17 years. 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: We 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.
Paul A Stricker, Laszlo Vutskits, Jurgen C de Graaff, Britta S von Ungern-Sternberg, Susan M Goobie, Yun-Xia Zuo, Tania A Ramos, Heidi M Meyer, Elsa M Taylor, Simon D Whyte, Claudia C Malic, Piedad C Echeverry, Wallis T Muhly, De-Ying Xie, Suellen M Walker, Cyrus Razavi, Alexandra M Torborg, Joseph P Cravero, C Dean Kurth, Ellen Rawlinson, Lei Yang, Ting Xu, M Ruth Graham, Rob Seal, Aine Sommerfield, Andrew J Davidson
Disease Category: Anaesthesia & pain control
Disease Name:
Age Range: 0 - 17
Sex: Either
Nature of Intervention: Surgery
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Delphi process
- Interview
- Survey
- Systematic review
Phase 1: Identify key pediatric candidate outcome domains and key pediatric sub-populations for COS development through structured expert consensus process.
Phase 2: Conduct systematic review to identify outcomes in relevant literature for sub-populations and domains identified in Phase 1. This systematic review will be followed by stakeholder consultation using a mixed-methods approach to explore the question of which outcomes matter most to children and families after anesthesia and surgery. An iterative Delphi process of relevant stakeholders (patients, parents, clinicians, researchers) will follow to rank candidate outcomes to be included in a COS.
Phase 3: Expert-based process to identify specific measures for outcomes identified in Phase 2. This process will involve a systematic review and a Delphi expert consensus process to identify outcome measures and/or need for specific validated outcome measures.