title: Protocol for a pragmatic cluster randomised controlled trial for reducing irrational antibiotic prescribing among children with upper respiratory infections in rural China.
abstract: Irrational use of antibiotics is a serious issue within China and internationally. In 2012, the Chinese Ministry of Health issued a regulation for antibiotic prescriptions limiting them to <20% of all prescriptions for outpatients, but no operational details have been issued regarding policy implementation. This study aims to test the effectiveness of a multidimensional intervention designed to reduce the use of antibiotics among children (aged 2-14 years old) with acute upper respiratory infections in rural primary care settings in China, through changing doctors' prescribing behaviours and educating parents/caregivers.
  
  
  
  This is a pragmatic, parallel-group, controlled, cluster-randomised superiority trial, with blinded evaluation of outcomes and data analysis, and un-blinded treatment. From two counties in Guangxi Province, 12 township hospitals will be randomised to the intervention arm and 13 to the control arm. In the control arm, the management of antibiotics prescriptions will continue through usual care via clinical consultations. In the intervention arm, a provider and patient/caregiver focused intervention will be embedded within routine primary care practice. The provider intervention includes operational guidelines, systematic training, peer review of antibiotic prescribing and provision of health education to patient caregivers. We will also provide printed educational materials and educational videos to patients' caregivers. The primary outcome is the proportion of all prescriptions issued by providers for upper respiratory infections in children aged 2-14 years old, which include at least one antibiotic.
  
  
  
  The trial has received ethical approval from the Ethics Committee of Guangxi Provincial Centre for Disease Control and Prevention, China. The results will be disseminated through workshops, policy briefs, peer-reviewed publications, local and international conferences.
  
  
  
  ISRCTN14340536; Pre-results.
authors.affiliation: China Global Health Research and Development, Shenzhen, China.
authors.forename: Guanyang
authors.initials: G
authors.lastname: Zou
authors.affiliation: China Global Health Research and Development, Shenzhen, China Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Xiaolin
authors.initials: X
authors.lastname: Wei
authors.affiliation: Nuffield Centre for International Health and Development, University of Leeds, Leeds, UK.
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Hicks
authors.affiliation: School of Public Health and Primary Care, Chinese University of Hong Kong, Hong Kong, China.
authors.forename: Yanhong
authors.initials: Y
authors.lastname: Hu
authors.affiliation: Nuffield Centre for International Health and Development, University of Leeds, Leeds, UK.
authors.forename: John
authors.initials: J
authors.lastname: Walley
authors.affiliation: Guangxi Autonomous Region Centre for Disease Control and Prevention, Nanning, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Zeng
authors.affiliation: Nuffield Centre for International Health and Development, University of Leeds, Leeds, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Elsey
authors.affiliation: Nuffield Centre for International Health and Development, University of Leeds, Leeds, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: King
authors.affiliation: China Global Health Research and Development, Shenzhen, China.
authors.forename: Zhitong
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: China Global Health Research and Development, Shenzhen, China.
authors.forename: Simin
authors.initials: S
authors.lastname: Deng
authors.affiliation: China Global Health Research and Development, Shenzhen, China.
authors.forename: Yuanyuan
authors.initials: Y
authors.lastname: Huang
authors.affiliation: Nuffield Centre for International Health and Development, University of Leeds, Leeds, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Blacklock
authors.affiliation: School of Public Health and Primary Care, Chinese University of Hong Kong, Hong Kong, China.
authors.forename: Jia
authors.initials: J
authors.lastname: Yin
authors.affiliation: Centre for Health Management and Policy, Shandong University, Jinan, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Sun
authors.affiliation: Guangxi Autonomous Region Centre for Disease Control and Prevention, Nanning, China.
authors.forename: Mei
authors.initials: M
authors.lastname: Lin
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017028:Caregivers / Q000193:education*; D002648:Child; D002675:Child, Preschool; D002681:China; D017723:Drug Utilization Review; D004502:Education, Medical, Continuing; D006801:Humans; D057970:Inappropriate Prescribing / Q000517:prevention & control*; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians'; D063487:Prescription Drug Misuse / Q000517:prevention & control*; D011320:Primary Health Care / Q000592:standards*; D012107:Research Design; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D012424:Rural Population; D016037:Single-Blind Method
chemical_list: D000900:Anti-Bacterial Agents
keywords: Antibiotics; China; Clustered randomized control trial; PRIMARY CARE; Rational use