Article Text

Original research
Gap between real-world data and clinical research within hospitals in China: a qualitative study
  1. Feifei Jin1,
  2. Chen Yao1,2,
  3. Xiaoyan Yan2,
  4. Chongya Dong1,
  5. Junkai Lai1,
  6. Li Li3,
  7. Bin Wang1,
  8. Yao Tan1,
  9. Sainan Zhu1
  1. 1Department of Biostatistics, Peking University First Hospital, Beijing, Beijing, China
  2. 2Peking University Clinical Research Institute, Beijing, Beijing, China
  3. 3First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, Tianjin, China
  1. Correspondence to Dr Chen Yao; yaochen{at}hsc.pku.edu.cn

Abstract

Objective To investigate the gap between real-world data and clinical research initiated by doctors in China, explore the potential reasons for this gap and collect different stakeholders’ suggestions.

Design This qualitative study involved three types of hospital personnel based on three interview outlines. The data analysis was performed using the constructivist grounded theory analysis process.

Setting Six tertiary hospitals (three general hospitals and three specialised hospitals) in Beijing, China, were included.

Participants In total, 42 doctors from 12 departments, 5 information technology managers and 4 clinical managers were interviewed through stratified purposive sampling.

Results Electronic medical record data cannot be directly downloaded into clinical research files, which is a major problem in China. The lack of data interoperability, unstructured electronic medical record data and concerns regarding data security create a gap between real-world data and research data. Updating hospital information systems, promoting data standards and establishing an independent clinical research platform may be feasible suggestions for solving the current problems.

Conclusions Determining the causes of gaps and targeted solutions could contribute to the development of clinical research in China. This research suggests that updating the hospital information system, promoting data standards and establishing a clinical research platform could promote the use of real-world data in the future.

  • qualitative research
  • health informatics
  • health policy

Data availability statement

Data are available upon reasonable request. Study protocol and original data are available on request by emailing the corresponding author.

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Data availability statement

Data are available upon reasonable request. Study protocol and original data are available on request by emailing the corresponding author.

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Footnotes

  • Correction notice This article has been corrected since it first published. The provenance and peer review statement has been included.

  • Contributors JFF, DCY, YXY and YC designed the study. JFF, DCY and TY collected the data. ZSN and YC contacted the respondents. JFF and WB analysed the data. JFF and LJK wrote the first draft of the manuscript. LL revised the manuscript. All authors contributed to the interpretation of the data and editing of the manuscript and approved the final manuscript. YC had full access to all data in the study and had final responsibility for the decision to submit for publication.

  • Funding This study was supported by the National Science and Technology Major Project of China (grant no. 2017ZX09304028-002).

  • Competing interests None declared.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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