The implementation of the guideline for the management of pediatric off-label use of drugs in China: a cross-sectional study

作者全名："Meng, Min; Hu, Jiale; Lei, Wenjuan; Tian, Min; Liu, Xiao; Lu, Yali; Liu, Enmei; Zhang, Shu; Han, Zhu; Li, Qiu; Chen, Yaolong"

作者地址："[Meng, Min; Chen, Yaolong] Chongqing Med Univ, Childrens Hosp, Chevidence Lab Child & Adolescent Hlth Dept, 136 Zhongshan Second St, Chongqing 400014, Peoples R China; [Meng, Min; Liu, Enmei; Zhang, Shu; Li, Qiu; Chen, Yaolong] Chongqing Med Univ, Natl Clin Res Ctr Child Hlth & Disorders, China Int Sci & Technol Cooperat Base Child Dev &, Key Lab Child Dev & Disorders,Minist Educ,Children, Chongqing, Peoples R China; [Meng, Min; Liu, Enmei; Zhang, Shu; Li, Qiu; Chen, Yaolong] Chongqing Key Lab Pediat, Chongqing, Peoples R China; [Meng, Min; Lei, Wenjuan; Tian, Min; Lu, Yali] Gansu Prov Hosp, Dept Pharm, Lanzhou, Peoples R China; [Hu, Jiale] Virginia Commonwealth Univ, Dept Nurse Anesthesia, Richmond, VA USA; [Liu, Xiao] Lanzhou Univ, Sch Publ Hlth, Lanzhou, Peoples R China; [Han, Zhu] Gansu Univ Chinese Med, Coll Pharm, Lanzhou, Peoples R China; [Li, Qiu] Chongqing Med Univ, Childrens Hosp, Dept Nephrol, 136 Zhongshan Second St, Chongqing 400014, Peoples R China; [Chen, Yaolong] Lanzhou Univ, Chinese Acad Med Sci, Sch Basic Med Sci, Res Unit Evidence Based Evaluat & Guidelines, 2021RU017, Lanzhou, Peoples R China; [Chen, Yaolong] WHO Collaborating Ctr Guideline Implementat & Know, Lanzhou, Peoples R China; [Chen, Yaolong] Lanzhou Univ, GRADE Ctr, Lanzhou, Peoples R China"

通信作者："Chen, YL (通讯作者)，Chongqing Med Univ, Childrens Hosp, Chevidence Lab Child & Adolescent Hlth Dept, 136 Zhongshan Second St, Chongqing 400014, Peoples R China.; Li, Q; Chen, YL (通讯作者)，Chongqing Med Univ, Natl Clin Res Ctr Child Hlth & Disorders, China Int Sci & Technol Cooperat Base Child Dev &, Key Lab Child Dev & Disorders,Minist Educ,Children, Chongqing, Peoples R China.; Li, Q; Chen, YL (通讯作者)，Chongqing Key Lab Pediat, Chongqing, Peoples R China.; Li, Q (通讯作者)，Chongqing Med Univ, Childrens Hosp, Dept Nephrol, 136 Zhongshan Second St, Chongqing 400014, Peoples R China.; Chen, YL (通讯作者)，Lanzhou Univ, Chinese Acad Med Sci, Sch Basic Med Sci, Res Unit Evidence Based Evaluat & Guidelines, 2021RU017, Lanzhou, Peoples R China.; Chen, YL (通讯作者)，WHO Collaborating Ctr Guideline Implementat & Know, Lanzhou, Peoples R China.; Chen, YL (通讯作者)，Lanzhou Univ, GRADE Ctr, Lanzhou, Peoples R China."

来源：TRANSLATIONAL PEDIATRICS

ESI学科分类：　

WOS号：WOS:001318826500014

JCR分区：Q2

影响因子：2

年份：2024

卷号：13

期号：8

开始页：　

结束页：　

文献类型：Article

关键词：Pediatric; cross-sectional studies; off-label use; questionnaires; China

摘要："Background: Previously, we developed the Guidelines for the Management of Pediatric Off-Label Use of Drugs in China in addressing the need for standardization of pediatric off-label drug use. As the implementation of recommendations in Guidelines among healthcare professionals is weak, it is important to identify barriers to guideline implementation for developing appropriate strategies for specific settings and target groups. This study aimed to assess the difficulty and urgency in implementing the recommendations in the Guideline, identifying the factors affecting the implementation of these recommendations to realize the clinical translation of the Guideline. Methods: A cross-sectional study was conducted from March 1 to June 17, 2022. Pediatricians, pharmacists, and health managers from all 31 mainland Chinese provinces were involved. The electronic questionnaires were distributed nationwide by The Clinical Pharmacology Group of the Pediatric Society of the Chinese Medical Association and the National Clinical Research Center for Child Health. Data analysis, including frequency, percentages, averages, and standard deviations was performed using Microsoft Excel 16.54. Chi- squared tests, multi-factor logistic regression, and linear regression were analyzed in SPSS 23.0. A Sankey diagram was constructed using R software. Results: A total of 869 valid questionnaires were collected from 491 participating organizations. More than half of the recommendations were implemented, and 12 recommendations were implemented more in tertiary hospitals than in secondary hospitals. The mean urgency scores of all 21 recommendations were over 5. The mean difficulty scores of all 21 recommendations were over 4. The percentage of the most urgent was 44.33%, and the least urgent was 1.45%. The most difficult portion was 12.03%, and the least difficult was 5.74%. Factors impacting the urgency and difficulty of guideline implementation were different, with common influences including the position, education level of clinicians and hospital level. Conclusions: The recommendations in the Guideline for the Management of Pediatric Off-Label Use of Drugs are considered highly urgent for implementation in China. Nevertheless, the study revealed challenges in applying all 21 recommendations within clinical practice. The key factors affecting implementation include the position, education, experience, and hospital level of healthcare professionals. It is recommended to facilitate implementing the recommendations by sharing experience across various hospital levels, starting from high-level hospitals and extending to primary healthcare settings. Moreover, adjustments to the professional structure within hospitals are needed to enhance the management of off-label drug use in pediatric patients."

基金机构：Chevidence Lab Child & Adolescent Health of Chongqing Medical University's Children's Hospital's Key Project in 2021

基金资助正文：This research was funded by the Chevidence Lab Child & Adolescent Health of Chongqing Medical University's Children's Hospital's Key Project in 2021. The study's design and execution were not influenced by the major project.