Suitability of databases in the <scp>Asia‐Pacific</scp> for collaborative monitoring of vaccine safety

Duszynski, Katherine; Stark, James H.; Cohet, Catherine; Huang, Wan Ting; Shin, Ju Young; Lai, Edward Chia Cheng; Man, Kenneth K C; Choi, Nam Kyong; Khromava, Alena; Kimura, Tomomi; Huang, Kui; Watcharathanakij, Sawaeng; Kochhar, Sonali; Chen, Robert T.; Pratt, Nicole

doi:10.1002/pds.5214

Cited by 5 publications

(6 citation statements)

References 59 publications

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“…Findings from a 2018 survey of electronic data sources suitable for vaccine research in the Asia‐Pacific region indicated that the YRHIP offers relevant vaccine‐specific outcome data 44 …”

Section: Resultsmentioning

confidence: 99%

“…Expert opinion ACPE in Xi'an provided an important opportunity to leverage insights on the suitability of various RWD sources for vaccine monitoring across the Asia-Pacific region. 44 Discussions organized during the conference between the authors and governmental, academic and industry experts enabled to better understand the RWD landscape and its challenges and opportunities.…”

Section: Resultsmentioning

confidence: 99%

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A feasibility assessment of real‐world data capabilities for monitoring vaccine safety and effectiveness in China: Human papillomavirus vaccination in the Yinzhou district as a use case

Welby

Feng

Tang

et al. 2023

Pharmacoepidemiology and Drug

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BackgroundReal‐world data (RWD) are increasingly used to generate real‐world evidence (RWE) of vaccine safety and effectiveness for regulatory purposes. Assessing feasibility of using RWD sources prior to implementing observational studies is recommended. As a use case, we described the process and findings of a feasibility assessment to identify reliable and relevant data sources for monitoring the safety and effectiveness of the AS04‐HPV‐16/18 human papillomavirus (HPV) vaccine in China.MethodsIterative multi‐step process: (1) targeted literature review and data source mapping; (2) expert opinion from national RWD experts; (3) survey to evaluate the identified data source operational infrastructure; and (4) continuous appraisal of published studies using the identified data source.ResultsThe Yinzhou Regional Health Information Platform (YRHIP) was identified as a data source of main interest, based on its large population coverage, high cervical cancer screening rates, and availability of adult electronic immunization records. Field meetings with national RWD experts confirmed its suitability for post‐authorization vaccine studies. Survey results showed that exposure data and relevant safety and effectiveness endpoints were recorded and linkable at the individual level across the platform. Iterative appraisal of emerging evidence from the literature corroborated these findings.ConclusionsThis feasibility assessment indicates that the YRHIP has the capacity to capture demographic, exposure, outcome and other data required to generate RWE on HPV vaccine safety and effectiveness in China. Studies using the YRHIP to monitor the AS04‐HPV‐16/18 vaccine in routine use building on this feasibility assessment are ongoing.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

A feasibility assessment of real‐world data capabilities for monitoring vaccine safety and effectiveness in China: Human papillomavirus vaccination in the Yinzhou district as a use case

Welby

Feng

Tang

et al. 2023

Pharmacoepidemiology and Drug

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“…7 Administrative claims data, derived from electronic data reported by healthcare providers and insurers for the purposes of reimbursement, provide an affordable and efficient way to monitor vaccine safety. 8 For example, Taiwan's National Health Insurance Research Database (NHIRD) has been utilized for research on influenza vaccination. 9 Recently, researchers of Norway and Denmark also conducted a population-based cohort study on the risk of CVST after administration of ChAdOx1-S (AstraZeneca) vaccine.…”

Section: Introductionmentioning

confidence: 99%

Positive Predictive Value of ICD-10 Codes for Cerebral Venous Sinus Thrombosis in Taiwan’s National Health Insurance Claims Database

Liao¹,

Shao²,

Lai³

et al. 2022

CLEP

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Objective: This study aims to determine the positive predictive value (PPV) of case definitions for cerebral venous sinus thrombosis (CVST) in Taiwan's National Health Insurance claims database based on the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnostic codes. Study Design and Setting: Inpatient records with ICD-10-CM codes of G08, I629, I636, or I676 were retrieved from the claims data of all hospital branches of Chang Gung Medical Foundation. Manual review of the medical records and images was performed in order to ascertain the diagnosis. The PPV of various case definitions for CVST was estimated. Results: Of the 380 hospitalizations, 166 and 214 were determined to be true-positive and false-positive episodes of acute CVST, respectively. The PPV of the ICD-10-CM codes of G08, I629, I636, and I676 was 88.2%, 2.0%, 100.0%, and 91.3%, respectively. The PPV generally increased when acute CVST was defined as a primary diagnosis or as ICD-10-CM codes plus anticoagulant use. Miscoding in other conditions, tentative diagnosis, and remote episode of CVST were determined as the main reasons for false-positive diagnosis of acute CVST. Conclusion:This study determined the PPV of ICD-10-CM codes for identifying CVST, which may offer a reference for future claims-based research.

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“…One limitation across the types of common epidemiological designs listed above is that there is often variation in vaccine data availability, as well as complexities in data access and data linkage requirements ( Duszynski et al, 2021 ). Generally, there is no one best study design that is superior over the other.…”

Section: Introductionmentioning

confidence: 99%

Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design

et al. 2022

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Post-marketing vaccine safety surveillance aims to detect adverse events following immunization in a population. Whether certain methods of surveillance are more precise and unbiased in generating safety signals is unclear. Here, we synthesized information from existing literature to provide an overview of the strengths, weaknesses, and clinical applications of epidemiologic and analytical methods used in vaccine monitoring, focusing on cohort, case-control and self-controlled designs. These designs are proposed to be evaluated in the EUMAEUS (Evaluating Use of Methods for Adverse Event Under Surveillance–for vaccines) study because of their widespread use and potential utility. Over the past decades, there have been an increasing number of epidemiological study designs used for vaccine safety surveillance. While traditional cohort and case-control study designs remain widely used, newer, novel designs such as the self-controlled case series and self-controlled risk intervals have been developed. Each study design comes with its strengths and limitations, and the most appropriate study design will depend on availability of resources, access to records, number and distribution of cases, and availability of population coverage data. Several assumptions have to be made while using the various study designs, and while the goal is to mitigate any biases, violations of these assumptions are often still present to varying degrees. In our review, we discussed some of the potential biases (i.e., selection bias, misclassification bias and confounding bias), and ways to mitigate them. While the types of epidemiological study designs are well established, a comprehensive comparison of the analytical aspects (including method evaluation and performance metrics) of these study designs are relatively less well studied. We summarized the literature, reporting on two simulation studies, which compared the detection time, empirical power, error rate and risk estimate bias across the above-mentioned study designs. While these simulation studies provided insights on the analytic performance of each of the study designs, its applicability to real-world data remains unclear. To bridge that gap, we provided the rationale of the EUMAEUS study, with a brief description of the study design; and how the use of real-world multi-database networks can provide insights into better methods evaluation and vaccine safety surveillance.

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

Cited by 5 publications

References 59 publications

A feasibility assessment of real‐world data capabilities for monitoring vaccine safety and effectiveness in China: Human papillomavirus vaccination in the Yinzhou district as a use case

A feasibility assessment of real‐world data capabilities for monitoring vaccine safety and effectiveness in China: Human papillomavirus vaccination in the Yinzhou district as a use case

Positive Predictive Value of ICD-10 Codes for Cerebral Venous Sinus Thrombosis in Taiwan’s National Health Insurance Claims Database

Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design

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