Preliminary assessment of the data appropriateness of electronic health records for real-world studies:A survey of hospitals in a developing region in China

To the Editor:Assessment of data appropriateness is a process to answer whether electronic health records(EHRs)from routine healthcare practices couldt intended study purposes,for example,available to be proceeded,with enough individual records,with relevant information able to be extracted from records,etc.[1-3]This has been increasingly underscored as a prerequisite when using EHRs(one important type of real-world data[RWD])for scientic purposes.[4-6]Although controversies remain on the denitions,types and assessment methods of the dimensions of RWD appropriateness,the latest ofcial guidelines(i.e.,from the U.S.Food and Drug Administration[FDA][4]and China National Medical Products Administration[NMPA][6])suggest that the assessment start from a preliminary stage on variable existence,and subsequently deepen into the issue of data value(such as missing value,outliers,etc.),as the preliminary assessment is the foundation of the overall RWD appropriateness.[7]Little is known about the appropriateness of EHRs in developing regions,which feature high visit volumes and a great number of hospitals.Therefore,this study aimed to preliminarily investigate RWD appropriateness from hospitals in developing regions from the perspective of core variables’comparison.

Progress of Active Surveillance for Vaccine Safety in China

Vaccination is one of the most cost-effective interventions for saving lives and promoting public health.The coronavirus disease 2019(COVID-19)pandemic is providing a stark reminder of the importance and power of vaccines(1).However,vaccines can cause harm,and their rare safety concerns have increased in relative visibility as successful control and prevention of vaccine preventable diseases has diminished awareness of these diseases.

Active Vaccine Safety Surveillance: Global Trends and Challenges in China

Importance.The great success in vaccine-preventable diseases has been accompanied by vaccine safety concerns.This has caused vaccine hesitancy to be the top 10 in threats to global health.The comprehensive understanding of adverse events following immunization should be entirely based on clinical trials and postapproval surveillance.It has increasingly been recognized worldwide that the active surveillance of vaccine safety should be an essential part of immunization programs due to its complementary advantages to passive surveillance and clinical trials.Highlights.In the present study,the framework of vaccine safety surveillance was summarized to illustrate the importance of active surveillance and address vaccine hesitancy or safety concerns.Then,the global progress of active surveillance systems was reviewed,mainly focusing on population-based or hospital-based active surveillance.With these successful paradigms,the practical and reliable ways to create robust and similar systems in China were discussed and presented from the perspective of available databases,methodology challenges,policy supports,and ethical considerations.Conclusion.In the inevitable trend of the global vaccine safety ecosystem,the establishment of an active surveillance system for vaccine safety in China is urgent and feasible.This process can be accelerated with the consensus and cooperation of regulatory departments,research institutions,and data owners.