JCIC Registry

Introduction

The Japanese Society of Congenital Interventional Cardiology (JCIC), an incorporated association, was established in 1998. For more than 20 years since its founding, we have been collecting cases of catheter interventions for congenital heart disease, Kawasaki disease, cardiomyopathy, arrhythmias, and other conditions in children and adults, primarily in Japan, but also from overseas. Since 1998, we have conducted all-Japan surveys on catheter interventions (procedures and complications), published annual reports, and presented them at academic conferences. In 2011, with the emergence of the internet and advances in online registration systems, we began working on registry construction. In 2013, the academic society established a steering committee to work on registry development. As a result, the JPIC Database was launched in January 2014, and the JCIC Registry (JCIC-R) was established to collect clinical practice data.

Complete Transition from Surveys to Registry

In 2013, prior to the registry launch, data collection began with 41 facilities. In 2013, the registry was an optional enrollment system, and the survey was also conducted in parallel. In January 2016, when the number of participating facilities reached 80, the survey was discontinued, and only the registry remained. The number of member facilities has been increasing year by year.

Survey Target Items

  • ・Benchmarking of procedures, including PDA, ASD, VSD, and other diagnoses, as well as risk assessment for complications by diagnosis
  • ・Clarification of data as registration conditions by the patients themselves
  • ・Public disclosure of new device approval processes, post-approval surveys, and appropriate use of devices determined by insurance coverage
  • ・Utilization for multi-center joint research approved by ethics committees, culture-based research, etc.
    And more.

Features

The JCIC Registry has the following five distinctive features:

1) System

This is an online registration system based on the NCD (National Clinical Database) that shares both the system infrastructure and patient basic information with JCVSD Congenital (Japan Cardiovascular Surgery Database Congenital). This enables low-cost system development, high registration rates, and sharing of diagnoses and medical histories for the same patients (eliminating the need for duplicate data entry).

2) Input Items

The minimum data set is based on the standardized nomenclature from major academic societies and has evolved year by year. Furthermore, in addition to input items required for web registration, academic society-designated questionnaire surveys and investigator-initiated research applications are collectively managed through a single input site and procedure application that does not impose additional burden on small facilities. This enables small-scale application research for Kawasaki disease patients or presentations on results by region (such as the number of cases by prefecture).

3) Data Submission to Academic Organizations

The following diagram illustrates the data submission process:

Data Flow:

Data entered into JCIC is aggregated by JCIC-affiliated academic societies. The aggregated data from the four relevant academic societies is reported to the academic society medical statistics committee at the University of Tokyo Graduate School of Medicine. The committee, composed of external experts, verifies the data content and utilization, and anonymously provides the data to the JCIC research committee for use in academic society research. After submission of the data utilization plan by the board, approval from the study ethics screening working group is obtained, and data is officially provided for utilization purposes.

4) Ethical Considerations

While patient personal information is handled with a high level of anonymization and encrypted communication and management, it is considered necessary to obtain ethics committee approval at each participating facility and obtain informed consent from each patient when handling data over the internet. We have been expanding the registry in accordance with the opt-in rule. Following the complete transition to the database at all facilities from January 2016, we were able to transition to the opt-out rule, similar to NCD registration in other medical fields.
"Opt-out rule": This is a method in which patients are notified of research participation or provided with disclosure opportunities at each participating facility. Unless patients express refusal, research participation is assumed. The information is posted on the facility's website, and the opt-out method is implemented to enable patients to refuse participation.

5) Monitoring

Ensuring the completeness and quality of data entry in the data obtained from the JCIC Registry is critical, and monitoring is essential. Since 2020, the JCIC Society has been conducting remote monitoring of 2 to 3 statistically significant facilities, taking into consideration the human resources and economic burden on audited sites. When the proportion of indeterminable items among the verification parameters exceeds a certain threshold, we switch to on-site monitoring to ensure high completeness and quality of data entry.

Summary

We are calling on all JCIC-affiliated facilities across Japan that perform catheter interventions not only for congenital heart disease from childhood through adulthood, but also for cardiovascular disorders associated with Kawasaki disease, pediatric ablation for tachyarrhythmias (including those with normal cardiac structures), and ablation for congenital heart disease (including adults), to participate in this registry. Recently, as this initiative has gained momentum, it has begun to be utilized for the introduction of new medical devices, post-marketing surveillance, promotion of research projects, and application to certification processes for specialists and operators.