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Development of a quality instrument for assessing the spontaneous reports of ADR/ADE using Delphi method in China

Abstract

Background and aim

The frequently low quality of submitted spontaneous reports is of an increasing concern; to our knowledge, no validated instrument exists for assessing case reports’ quality comprehensively enough. This work was conducted to develop such a quality instrument for assessing the spontaneous reports of adverse drug reaction (ADR)/adverse drug event (ADE) in China.

Methods

Initial evaluation indicators were generated using systematic and literature data analysis. Final indicators and their weights were identified using Delphi method. The final quality instrument was developed by adopting the synthetic scoring method.

Results

A consensus was reached after four rounds of Delphi survey. The developed quality instrument consisted of 6 first-rank indicators, 18 second-rank indicators, and 115 third-rank indicators, and each rank indicator has been weighted. It evaluates the quality of spontaneous reports of ADR/ADE comprehensively and quantitatively on six parameters: authenticity, duplication, regulatory, completeness, vigilance level, and reporting time frame.

Conclusion

The developed instrument was tested with good reliability and validity, which can be used to comprehensively and quantitatively assess the submitted spontaneous reports of ADR/ADE in China.

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Acknowledgments

The authors thank the following experts for their participation: Le-jie Cao, Fei-hu Chen, Li-ming Chen, Yi-xin Chen, Hong Ding, Wen Fu, Dai-hong Gou, Chuan-hai Huang, Qi-cheng Jiang, Xiao-bin Li, Xiong-wen Lv, Fa-ming Pan, Xiu-qin Su, Jun Sun, Yan-cai Sun, Hai-sun Wang, Da-you Wang, Jing Wang, Li Wang, Yu-hong Wang, Hua-wen Xin, Wen-ke Xu, Mu Yang, Si-yan Zhan, Qin Zhang, Shan-tang Zhang, Wei-dong Zhang.

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Correspondence to Lixun Chen.

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Chen, L., Jiang, L., Shen, A. et al. Development of a quality instrument for assessing the spontaneous reports of ADR/ADE using Delphi method in China. Eur J Clin Pharmacol 72, 1135–1142 (2016). https://doi.org/10.1007/s00228-016-2081-6

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  • DOI: https://doi.org/10.1007/s00228-016-2081-6

Keywords

  • Adverse drug reaction
  • Adverse drug event
  • Case report
  • Delphi method
  • Quality instrument