Suitability of databases in the Asia-Pacific for collaborative monitoring of vaccine safety

Introduction: Information regarding availability of electronic healthcare databases in the Asia-Pacific region is critical for planning vaccine safety assessments particularly, as COVID-19 vaccines are introduced. This study aimed to identify data sources in the region, potentially suitable for vaccine safety surveillance. This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE). Methods: Nineteen countries targeted for database reporting were identified using published country lists and review articles. Surveillance capacity was assessed using two surveys: a 9-item introductory survey and a 51-item full survey. Survey questions related to database characteristics, covariate and health outcome variables, vaccine exposure characteristics, access and governance, and dataset linkage capability. Other questions collated research/regulatory applications of the data and local publications detailing database use for research. Results: Eleven databases containing vaccine-specific information were identified across 8 countries. Databases were largely national in coverage (8/11, 73%), encompassed all ages (9/11, 82%) with population size from 1.4 to 52 million persons. Vaccine exposure information varied particularly for standardized vaccine codes (5/11, 46%), brand (7/11, 64%) and manufacturer (5/11, 46%). Outcome data were integrated with vaccine data in 6 (55%) databases and available via linkage in 5 (46%) databases. Data approval processes varied, impacting on timeliness of data access. Conclusions: Variation in vaccine data availability, complexities in data access including, governance and data release approval procedures, together with requirement for data linkage for outcome information, all contribute to the challenges in building a distributed network for vaccine safety assessment in the Asia-Pacific and globally. Common data models (CDMs) may help expedite vaccine safety research across the region

Global epidemiology of hip fractures: a study protocol using a common analytical platform among multiple countries

INTRODUCTION: Hip fractures are associated with a high burden of morbidity and mortality. Globally, there is wide variation in the incidence of hip fracture in people aged 50 years and older. Longitudinal and cross-geographical comparisons of health data can provide insights on aetiology, risk factors, and healthcare practices. However, systematic reviews of studies that use different methods and study periods do not permit direct comparison across geographical regions. Thus, the objective of this study is to investigate global secular trends in hip fracture incidence, mortality and use of postfracture pharmacological treatment across Asia, Oceania, North and South America, and Western and Northern Europe using a unified methodology applied to health records. METHODS AND ANALYSIS: This retrospective cohort study will use a common protocol and an analytical common data model approach to examine incidence of hip fracture across population-based databases in different geographical regions and healthcare settings. The study period will be from 2005 to 2018 subject to data availability in study sites. Patients aged 50 years and older and hospitalised due to hip fracture during the study period will be included. The primary outcome will be expressed as the annual incidence of hip fracture. Secondary outcomes will be the pharmacological treatment rate and mortality within 12 months following initial hip fracture by year. For the primary outcome, crude and standardised incidence of hip fracture will be reported. Linear regression will be used to test for time trends in the annual incidence. For secondary outcomes, the crude mortality and standardised mortality incidence will be reported. ETHICS AND DISSEMINATION: Each participating site will follow the relevant local ethics and regulatory frameworks for study approval. The results of the study will be submitted for peer-reviewed scientific publications and presented at scientific conferences

Databases in Asia: the potential for distributed network approach

Poster: no. 689This journal suppl. entitled: Special Issue: Abstracts of the 30th International Conference on Pharmacoepidemiology and Therapeutic Risk Management ... 2014BACKGROUND: One of the initial steps to establish a distributed network approach for collaborative multinational studies in Asia is to understand the applicability of a common data model (CDM) to heterogeneous data sources. However, the capacity of database in Asian countries and the feasibility to build or apply existing CDM has not been well described. OBJECTIVES: To describe database availability and characteristics of the databases in Asian countries and to assess the feasibility to apply a CDM in Asian database environments. METHODS: A web-based survey was conducted among investigators using healthcare databases in Asia. The potential survey participants were identified through the Asian Pharmacoepidemiology Network. The survey included questions: 1) characteristics of database, 2) patients demographics, 3) data components and coding system 4) medical expenditure, and 5) the traditional Chinese medicine (TCM) or complementary medicine. RESULTS: A total of 10 data sources from Asian countries participated in the survey, including nationwide databases form Japan, Korea, Taiwan, and Hong Kong. These contained data on approximately 128, 50, 23, and 7 million individuals, respectively, covering all age groups and the majority was Asian. One claims database includes all veterans and dependents (approximately 330,000 individuals) from Australia with predominantly elderly and Caucasian. Others included a hospital based EHR from China (5 million individuals) and two EHRs from Thailand (1 million and 300,000 individuals). Two registries for cancer and stroke were from Taiwan. The majority of databases possesses diagnoses information with the date by either ICD9 or ICD10 codes; and encompasses procedures and prescriptions records with the date by domestic coding systems. Three databases contain dispensing data for TCMs. One EHR includes information of Thai herbal medicine. CONCLUSIONS: There are numerous Asian databases with comprehensive healthcare information to provide an opportunity for applying distributed network approach in Asia. Harmonization of the coding systems as well as understanding practice patterns affecting the interpretation of results will be challenges for multinational database studies

Databases in the Asia-pacific region: The potential for a distributed network approach

Background: This study describes the availability and characteristics of databases in Asian-Pacific countries and assesses the feasibility of a distributed network approach in the region. Methods: A web-based survey was conducted among investigators using healthcare databases in the Asia-Pacific countries. Potential survey participants were identified through the Asian Pharmacoepidemiology Network. Results: Investigators from a total of 11 databases participated in the survey. Database sources included four nationwide claims databases from Japan, South Korea, and Taiwan; two nationwide electronic health records from Hong Kong and Singapore; a regional electronic health record from western China; two electronic health records from Thailand; and cancer and stroke registries from Taiwan. Conclusions: We identified 11 databases with capabilities for distributed network approaches. Many country-specific coding systems and terminologies have been already converted to international coding systems. The harmonization of health expenditure data is a major obstacle for future investigations attempting to evaluate issues related to medical costs