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Protocol for a multicentre, multistage, prospective study in China using system-based approaches for consistent improvement in surgical safety
  1. Xiaochu Yu1,
  2. Jingmei Jiang2,
  3. Changwei Liu1,
  4. Keng Shen1,
  5. Zixing Wang2,
  6. Wei Han2,
  7. Xingrong Liu1,
  8. Guole Lin1,
  9. Ye Zhang1,
  10. Ying Zhang1,
  11. Yufen Ma1,
  12. Haixin Bo1,
  13. Yupei Zhao1
  1. 1 Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China
  2. 2 Department of Epidemiology and Biotatistics, Institute of Basic Medicine Sciences, Chinese Academy of Medical Sciences, Beijing, China
  1. Correspondence to Dr Xiaochu Yu; yuxch{at}pumch.cn and Dr Yupei Zhao; yupeizhao_1929{at}sina.com

Abstract

Introduction Surgical safety has emerged as a crucial global health issue in the past two decades. Although several safety-enhancing tools are available, the pace of large-scale improvement remains slow, especially in developing countries such as China. The present project (Modern Surgery and Anesthesia Safety Management System Construction and Promotion) aims to develop and validate system-based integrated approaches for reducing perioperative deaths and complications using a multicentre, multistage design.

Methods and analysis The project involves collection of clinical and outcome information for 1 20 000 surgical inpatients at four regionally representative academic/teaching general hospitals in China during three sequential stages: preparation and development, effectiveness validation and improvement of implementation for promotion. These big data will provide the evidence base for the formulation, validation and improvement processes of a system-based stratified safety intervention package covering the entire surgical pathway. Attention will be directed to managing inherent patient risks and regulating medical safety behaviour. Information technology will facilitate data collection and intervention implementation, provide supervision mechanisms and guarantee transfer of key patient safety messages between departments and personnel. Changes in rates of deaths, surgical complications during hospitalisation, length of stay, system adoption and implementation rates will be analysed to evaluate effectiveness and efficiency.

Ethics and dissemination This study was approved by the institutional review boards of Peking Union Medical College Hospital, First Hospital of China Medical University, Qinghai Provincial People’s Hospital, Xiangya Hospital Central South University and the Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences. Study findings will be disseminated via peer-reviewed journals, conference presentations and patent papers.

  • patient safety
  • surgical complication
  • risk management
  • hospital information system

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 Conception and writing of protocol: XY and JJ. Participation in collaborator meeting, development of study concept and editing of protocol: XY, JJ, CL, KS, ZW, WH, XL, GL, Ye Zhang, Ying Zhang, YM, HB and Yupei Zhao. Guarantor: XY and Yupei Zhao. All authors read and approved the final manuscript.

  • Funding This work was supported by the National Health and Family Planning Commission of China, grant number: 201402017.

  • Competing interests None declared.

  • Patient consent The review boards waived the need for patient and medical staff consent as individual information is not disclosed.

  • Ethics approval The institutional review boards of Peking Union Medical College Hospital, First Hospital of China Medical University, Qinghai Provincial People’s Hospital, Xiangya Hospital Central South University and the Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences.

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

  • Correction notice This paper has been amended since it was published Online First. Owing to a scripting error, some of the publisher names in the references were replaced with 'BMJ Publishing Group'. This only affected the full text version, not the PDF. We have since corrected theseerrors and the correct publishers have been inserted into the references.

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