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Core Outcome Sets for Pediatric Perioperative Research: An International Stakeholder Engagement Exercise and
Paul A Stricker1, Laszlo Vutskits2, Jurgen C de Graaff3
1Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Insights
This study developed core outcome sets for pediatric perioperative research, ensuring patient-centered outcomes are consistently reported in clinical trials for better intervention assessment.
Area of Science:
- Pediatric Perioperative Medicine
- Clinical Trial Methodology
- Patient-Reported Outcomes
Background:
- Standardized outcome reporting is crucial for evaluating pediatric perioperative interventions.
- Patient and parent perspectives are vital in identifying meaningful clinical research outcomes.
- The study addresses the need for consistent outcome measures in pediatric surgical care.
Purpose of the Study:
- To develop and establish core outcome sets for pediatric perioperative research.
- To ensure that outcomes important to patients and their guardians are prioritized.
- To facilitate consistent and comparable assessments of interventions across pediatric surgical trials.
Main Methods:
- A stepwise approach following the COMET initiative guidelines was employed.
- Extensive international stakeholder engagement included surveys of patients, parents/guardians, and healthcare providers.
- A Delphi process with expert representatives and virtual meetings finalized the core outcome sets.
Main Results:
- 1,178 subjects participated in the international stakeholder survey across multiple countries.
- Core outcome sets were unanimously agreed upon for neonates, infants, children (1-12 years), and adolescents (13-17 years).
- Key outcomes included adverse events, pain management, and unplanned medical attention, with quality of recovery and return to function also identified.
Conclusions:
- Core outcome sets for pediatric perioperative research have been successfully identified for four distinct age groups.
- These standardized outcomes should be incorporated into future pediatric perioperative studies.
- The developed sets enhance the relevance and comparability of research findings in pediatric surgical care.
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.
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