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


CONCLUSIONS
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.
Zhejiang Food and Drug Administration, Hangzhou, China. chenlixun@outlook.com.
Lixun
L
Chen
Provincial Hospital Affiliated to Anhui Medical University, Hefei, China.
Ling
L
Jiang
Provincial Hospital Affiliated to Anhui Medical University, Hefei, China.
Aizong
A
Shen
Institute of Clinical Pharmacology, Anhui Medical University, Key Laboratory of Anti-inflammatory and Immunopharmacology of Education Ministry of China, Hefei, China.
Wei
W
Wei
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D002681:China; D003697:Delphi Technique; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D060735:Pharmacovigilance
Adverse drug event; Adverse drug reaction; Case report; Delphi method; Quality instrument