Objective  To systematically review the quality of pediatric off-label medication guidelines and consensus, compare the differences among guidelines and consensus, and to provide recommendations for clinical application.

Method  Searching the guidelines and literature databases and websites such as TRIP, GIN, NICE, PubMed, CNKI, WanFang Data, MedLink, to collect off-label drug use guidelines or consensus. The AGREE II was used to evaluate the methodological quality of the included guidelines or consensus, and the differences among the recommendations of guidelines and consensus were analyzed and compared. The differences in scores between guidelines and consensus and international and domestic guidelines and consensus were compared in each domain.

Results  A total of 7 papers were included, comprising 3 guidelines and 4 consensuses, 1 from Austria and 6 from China. The AGREE II results showed that the scores of 2 domains, “Scope and Purpose” and “Stakeholder Involvement”, were above 60%. There were significant differences in scores in the remaining four domains (Rigour of Development, Clarity of Presentation, Applicability, and Editorial Independence). There were differences in the insufficient items of the guidelines and consensus. The “Scope and Purpose” of the guidelines scored significantly higher than the consensus. In addition, the grading of evidence and grading of recommendations of the guidelines and consensus were different, including GRADE, Micromedex, Oxford Centre for Evidence-based Medicine standards, and custom methods. According to the AGREE II, among the 7 guidelines and consensus, 3 were recommended, 3 were recommended after modification, and 1 was not recommended.

Conclusion  There are relatively few existing pediatric guidelines and consensus on off-label medication. At present, there are differences in the quality of guidelines and consensus, with inconsistent standards for evidence quality and recommendation strength.

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