BACKGROUND Comprehensive safety data for vaccines from post-licensure surveillance, especially active surveillance, could guide administrations and individuals to make reasonable decisions on vaccination. Therefore, we designed a pilot study to assess the capability of a regional health care information platform to actively monitor the safety of a newly licensed vaccine. OBJECTIVE This study aimed to conduct active surveillance of human papillomavirus (HPV) vaccine safety based on this information platform. METHODS In 2017, one of China’s most mature information platforms with superior data linkage was selected. A structured questionnaire and open-ended interview guidelines were developed to investigate the feasibility of active surveillance following HPV vaccination using the regional health care information platform in Ningbo. The questionnaire was sent to participants via email, and a face-to-face interview was conducted to confirm details or resolve discrepancies. RESULTS Five databases that could be considered essential to active surveillance of vaccine safety were integrated into the platform starting in 2015. Except for residents' health records, which had a coverage rate of 87%, the data sources covered more than 95% of the records that were documented in Ningbo. All the data could be inherently linked using the national identity card. There were 19,328 women who received the HPV vaccine, and 37,988 doses were administered in 2017 and 2018. Women aged 30-40 years accounted for the largest proportion. Quadrivalent vaccination accounted for 73.1% of total vaccination, a much higher proportion than that of bivalent vaccination. Of the first doses, 60 (60/19,328, 0.31%) occurred outside Ningbo. There were no missing data for vaccination-relevant variables, such as identity card, vaccine name, vaccination doses, vaccination date, and manufacturer. ICD-10 coding could be used to identify 9,180 cases using a predefined list of the outcomes of interest, and 1.88% of these cases were missing the identity card. During the 90 days following HPV vaccination, 4 incident cases were found through the linked vaccination history and electronic medical records. The combined incident rate of rheumatoid arthritis, optic neuritis, and Henoch-Schonlein purpura was 8.84/100,000 doses of bivalent HPV, and the incidence rate of rheumatoid arthritis was 3.75/100,000 doses of quadrivalent HPV. CONCLUSIONS This study presents an available approach to initiate an active surveillance system for adverse events following HPV vaccination, based on a regional health care information platform in China. An extended observation period or the inclusion of additional functional sites is warranted to conduct future hypothesis-generating and hypothesis-confirming studies for vaccine safety concerns.

BACKGROUND Noncommunicable diseases (NCDs) have become the main public health concern worldwide. With rapid economic development and changes in lifestyles, the burden of NCDs in China is increasing dramatically every year. Monitoring is a critical measure for NCDs control and prevention. However, because of the lack of regional representativeness, unsatisfactory data quality, and inefficient data sharing and utilization, the existing surveillance systems and surveys in China cannot track the status and transition of NCDs epidemic. OBJECTIVE To efficaciously track NCDs epidemic in China, this pilot program conducted in Ningbo city by the Chinese Center for Disease Control and Prevention (CDC) aimed to develop an innovative model for NCDs surveillance and management: the integrated noncommunicable disease collaborative management system (NCDCMS). METHODS This Ningbo model was designed and developed through a 3-level (county/district, municipal, and provincial levels) direct reporting system based on the regional health information platform. The uniform data standards and interface specifications were established to connect different platforms and conduct data exchanges. The performance of the system was evaluated based on the 9 attributes of surveillance system evaluation framework recommended by the US CDC. RESULTS NCDCMS allows automatic NCDs data exchanging and sharing via a 3-level public health data exchange platform in China. It currently covers 201 medical institutions throughout the city. Compared with previous systems, automatic popping up of the report card, automatic patient information extraction, and real-time data exchange process have highly improved the simplicity and timeliness of the system. The data quality meets the requirements to monitor the incidence trend of NCDs accurately, and the comprehensive data types obtained from the database (ie, directly from the 3-level platform on the data warehouse) also provide a useful information to conduct scientific studies. So far, 98.1% (201/205) of medical institutions across Ningbo having been involved in data exchanges with the model. Evaluations of the system performance showed that NCDCMS has high levels of simplicity, data quality, acceptability, representativeness, and timeliness. CONCLUSIONS NCDCMS completely reshaped the process of NCD surveillance reporting and had unique advantages, which include reducing the work burden of different stakeholders by data sharing and exchange, eliminating unnecessary redundancies, reducing the amount of underreporting, and structuring population-based cohorts. The Ningbo model will be gradually promoted elsewhere following this success of the pilot project, and is expected to be a milestone in NCDs surveillance, control, and prevention in China.