{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T09:59:33Z","timestamp":1790330373744,"version":"4.1.0"},"reference-count":42,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,8,30]],"date-time":"2026-08-30T00:00:00Z","timestamp":1788048000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,30]],"date-time":"2026-08-30T00:00:00Z","timestamp":1788048000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Evidence Based Medicine"],"published-print":{"date-parts":[[2026,9]]},"abstract":"ABSTRACT<\/jats:title>\n \n Objective<\/jats:title>\n To develop and validate a rapid, evidence\u2010based benefit\u2013risk assessment index for off\u2010label drug use in pediatrics, thereby promoting standardized clinical decision\u2010making.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n 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\u2010based validation involved 20 hematology\u2010oncology experts assessing 10 cases; intraclass correlation coefficient (ICC) and Spearman's correlations evaluated reliability and validity.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The index consists of 2 primary dimensions (benefits: 56 points; risks: 44 points), 10 third\u2010level, and 40 fourth\u2010level indicators, with five prerequisites (e.g., no alternatives, informed consent). The ICC was 0.77 (good reliability); Spearman's correlations were\n \n r\n s<\/jats:sub>\n <\/jats:italic>\n = 0.97 (benefits) and\n \n r\n s<\/jats:sub>\n <\/jats:italic>\n = 0.68 (risks) (both\n p<\/jats:italic>\n < 0.05), indicating strong alignment with expert consensus. Junior experts showed lower correlations (benefits\n \n r\n s<\/jats:sub>\n <\/jats:italic>\n = 0.89; risks\n \n r\n s<\/jats:sub>\n <\/jats:italic>\n = 0.56) than seniors (benefits\n \n r\n s<\/jats:sub>\n <\/jats:italic>\n = 0.97; risks\n \n r\n s<\/jats:sub>\n <\/jats:italic>\n = 0.78), highlighting the system's role in standardizing assessments.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n This quantitative index provides an evidence\u2010based tool for pediatric off\u2010label drug decisions, supporting clinicians, policymakers, and standardization efforts.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/jebm.70177","type":"journal-article","created":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T06:19:06Z","timestamp":1788157146000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development and Validation of a Rapid Benefit\u2013Risk Assessment Index for Pediatric Off\u2010Label Drug 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