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Paediatric asthma control under a community management model in China: a protocol for a prospective multicentre cohort study

Abstract

Introduction Childhood asthma is globally one of the most common respiratory disorders and accounts for more school absences and more hospitalizations than any other chronic illness. The worldwide economic burden of this disease exceeds those of HIV/AIDS and tuberculosis combined. Proper intervention and effective management is of paramount importance for the control and prognosis of paediatric asthma. Unfortunately, the rate of uncontrolled and partially controlled paediatric asthma in China is >90%. This study will use a new management model to investigate the status of asthma control and the adherence of patients to a medication protocol.

Methods This prospective, multicentre, observational study will be conducted at 15 hospitals on children (n=800) diagnosed with asthma. Each patient will be assigned to either the nearest community hospital or Shanghai Children's Medical Center, whichever is closer to the patient's home, according to the decision of parents. Participants were divided into two groups: tertiary care hospital (Shanghai Children's Medical Center) follow-up group and community hospital follow-up group. The primary outcome will be the difference in the proportion of controlled, partially controlled and uncontrolled asthma among the two groups. Secondary outcomes will be the differences in adherence rate, lung function, exacerbations, growth development, total asthma-related unscheduled visits, days absent from school and loss of working days for the patient's caregiver. Data will be analysed on an intention-to-treat and a per-protocol basis.

Ethics and dissemination Ethics approval was obtained from the Institutional Review Board of Shanghai Children's Medical Center affiliated with Shanghai Jiao Tong University of Medicine. We plan to publish the results of this study in a peer-reviewed journal article.

  • paediatrics
  • asthma
  • China

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors JX contributed to the drafting of the manuscript. YY conceived of and designed the study. HZ, WWZ, LZ and JZ made substantial contributions to study design. SHY provided statistical support. FZ, SHY and LXZ were responsible for collecting data. All authors will be involved in writing the manuscript and revising it critically for intellectual content, and all will give final approval of the version to be published.

  • Funding This project was funded by the Science and Technology Commission of Shanghai Municipality (No. SHDC12016216) and Shanghai Shen-kang Hospital Development Center Projects for the Prevention and Control of Chronic Diseases (No. SHDC12015306). It was also funded by the Key Projects of Shanghai Science and Technology Department of Medicine (16411955100) and by the Three Years ActionPlan to Promote Clinical Skills and Clinical Innovation Capability in Municipal Hospitals (16CR4002A).

  • Competing interests None declared.

  • Patient consent Parental/guardian consent obtained.

  • Ethics approval Institutional Review Board of Shanghai Children's Medical Center affiliated to Shanghai Jiao Tong University of Medicine.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Collaborators Sheng Chen and Lihua Qin, Beicai Community Health Service Center, Shanghai, China. Ying He and Yiqin Cai, Heqing Community Health Service Center, Shanghai, China. Qunzhi Wu, Lianyang Community Health Service Center, Shanghai, China. Huihua Qiao and Xiaoqin Liu, Hudong Community Health Service Center, Shanghai, China. Binbin Zhang and Dandan Mo, Jinyang Community Health Service Center, Shanghai, China. Lanping Ye, Zhuqiao Community Health Service Center, Shanghai, China. Lingjun Liu and Yumin Zhang, Lujiazui Community Health Service Center, Shanghai, China. Qinqin Lu and Yan Yin, Gaoqiao Community Health Service Center, Shanghai, China. Hui Dai, Sanlin Community Health Service Center, Shanghai, China. Lihua Qu, Datuan Community Health Service Center, Shanghai, China. Yichun Yuan, Yangjing Community Health Service Center, Shanghai, China. Zhigang Zhou, Tangqiao Community Health Service Center, Shanghai, China. Wei Feng, Huinan Community Health Service Center, Shanghai, China. Yanping Wang, Nicheng Community Health Service Center, Shanghai, China.

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