Vollständiger Abstract
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ABSTRACT Objective To develop and validate a rapid, evidence‐based benefit–risk assessment index for off‐label drug use in pediatrics, thereby promoting standardized clinical decision‐making. Methods Under the auspices of the Guangdong Pharmaceutical Association, a multidisciplinary expert panel from pediatrics, pharmacy, methodology, and ethics was convened. Systematic literature searches informed a preliminary index framework. Three Delphi rounds refined indicators. Weights were assigned using the analytic hierarchy process. Expert‐based validation involved 20 hematology‐oncology experts assessing 10 cases; intraclass correlation coefficient (ICC) and Spearman's correlations evaluated reliability and validity. Results The index consists of 2 primary dimensions (benefits: 56 points; risks: 44 points), 10 third‐level, and 40 fourth‐level indicators, with five prerequisites (e.g., no alternatives, informed consent). The ICC was 0.77 (good reliability); Spearman's correlations were r s = 0.97 (benefits) and r s = 0.68 (risks) (both p < 0.05), indicating strong alignment with expert consensus. Junior experts showed lower correlations (benefits r s = 0.89; risks r s = 0.56) than seniors (benefits r s = 0.97; risks r s = 0.78), highlighting the system's role in standardizing assessments. Conclusion This quantitative index provides an evidence‐based tool for pediatric off‐label drug decisions, supporting clinicians, policymakers, and standardization efforts.
Bibliografischer Nachweis
Publikationsdaten
- Autor:innen
- Xuejuan Li, Yingna Xu, Guanglei Jin, Wei Jiang, Zebin Chen, Zhihua Zheng, Xiaoling Wang, Xiaolan Mo, Xinyu Liu, Benjie Zhou, Hong Chang, Shaojie Deng, Xiaomei Fan, Jinping Wang, Yuntao Jia, Zhong Li, Jing Miao, Yunzhu Lin, Rui Fang, Zhiling Li, Jianhong Zhu, Zhichao He, Yinghui Jin, Qiru Su, Wudong Guo, Jie Jiang, Sha Li, Jinqiu Yuan, Jun Yang, Sixi Liu, Zhe Su, Yanmin Bao, Dezhi Cao, Zhaoxia Wang, Weiping Tan, Bihong Zhang, Chunxiu Gong, Xiaodong Wang, Zhiyong Zhang, Chunhong Xie
- Quelle
- Journal of Evidence-Based Medicine
- Publikation
- 2026-01-01
- Band / Ausgabe
- Nicht angegeben
- Seiten
- Nicht angegeben
- ISSN / ISBN
- 1756-5383, 1756-5391
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Zitierfähiger Nachweis
Xuejuan Li, Yingna Xu, Guanglei Jin, Wei Jiang, Zebin Chen, Zhihua Zheng, Xiaoling Wang, Xiaolan Mo, Xinyu Liu, Benjie Zhou, Hong Chang, Shaojie Deng, Xiaomei Fan, Jinping Wang, Yuntao Jia, Zhong Li, Jing Miao, Yunzhu Lin, Rui Fang, Zhiling Li, Jianhong Zhu, Zhichao He, Yinghui Jin, Qiru Su, Wudong Guo, Jie Jiang, Sha Li, Jinqiu Yuan, Jun Yang, Sixi Liu, Zhe Su, Yanmin Bao, Dezhi Cao, Zhaoxia Wang, Weiping Tan, Bihong Zhang, Chunxiu Gong, Xiaodong Wang, Zhiyong Zhang, Chunhong Xie (2026). Development and Validation of a Rapid Benefit–Risk Assessment Index for Pediatric Off‐Label Drug Use. Journal of Evidence-Based Medicine. https://doi.org/10.1111/jebm.70177
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