Clinical epidemiology and pharmacoepidemiology studies with real-world databases

Yoshida, Satohiro; Takeuchi, Masato; Tanaka‐Mizuno, Sachiko; Mizuno, Kayoko; Nakashima, Masayuki; Fukasawa, Toshiki; Kawakami, Koji

doi:10.2183/pjab.98.026

Cited by 17 publications

(5 citation statements)

References 101 publications

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“…The literature on RWD practices and awareness about corresponding warehouses in certain Asian countries like China, Japan, and South Korea is significant [5,[9][10][11][12][13][14][15][16][17], partly because these countries also have recommendations on the utility of RWE by external regulators [3]. This study seeks to understand the evolving landscape of RWD utilization and its implications across Hong Kong, Indonesia, Malaysia, Pakistan, the Philippines, Singapore, and Vietnam, where RWD practices are emerging or undergoing significant development [4].…”

Section: Methodsmentioning

confidence: 99%

Integrated Real-World Data Warehouses Across 7 Evolving Asian Health Care Systems: Scoping Review

Shau,

Santoso,

Jip

et al. 2024

J Med Internet Res

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Background: Asia consists of diverse nations with extremely variable healthcare systems and socio-economic intricacies. Integrated real-world data (RWD) research warehouses provide vast interconnected datasets that uphold statistical rigor. However, their intricate details remain underexplored, restricting their broader application in healthcare research, policies and partnerships.Objective: Building on our prior research that analyzed integrated RWD warehouses in India, Thailand and Taiwan, this study is an extension to seven distinct Asian healthcare systems: Hong Kong, Indonesia, Malaysia, Pakistan, the Philippines, Singapore, and Vietnam. We aimed to map the evolving landscape of RWD use, elucidate the current state of real-world evidence (RWE) generation from integrated databases, and understand evolving preferences for RWD methodologies and database(s) use. Methods:A systematic scoping review methodology was employed, centering on contemporary English literature search on PubMed. Rigorous screening followed defined eligibility criteria to pinpoint studies utilizing integrated RWD from multiple healthcare facilities in at least one of the seven target Asian nations. Target nations were archetyped as 'Global Collaborators' or 'Solo Scholars' based on their publication count and extent of Cross-Country Collaboration Studies (CCCS) versus Single Country Studies (SCS) over the five-year study period.Results: Out of the 1483 RWE research titles identified on May 9, 2023, 369 (24.9%) fulfilled the requirements for data extraction and subsequent analysis. Singapore, Hong Kong, and Malaysia contributed to ?100 publications, each marked by a higher proportion of SCS at 51% (80/157), 66.2% (86/130), and 50% (50/100), respectively, and were classified as Solo Scholars. Indonesia, Pakistan, Vietnam and the Philippines had fewer publications and a higher proportion of CCCS at 78.8% (26/33), 58.1% (18/31), 74.1% (20/27), and 86.4% (19/22), respectively and were classified as Global Collaborators. Collaboration with the countries outside the seven target nations appeared in 84.2%-97.7% of the CCCS of each nation. Among target nations, Singapore and Malaysia emerged as preferred research partners for other nations. From 2018 to 2023, most nations displayed an increasing trend in study numbers, with Vietnam (24.5%) and Pakistan (21.2%) leading the growth; the only exception was the Philippines, which declined by -14.5%. Clinical registry databases were predominant across all CCCS from every target nation. For SCS, Indonesia, Malaysia, and the Philippines favored clinical registries; Singapore had a balanced usage of clinical registries and EMR/EHR, while Hong Kong, Pakistan, and Vietnam leaned towards EMR/EHR. Over 90% of the studies took more than 2 years from completion to publication. Conclusions:The observed variations in contemporary RWD publications across the 7 nations in Asia exemplify distinct research landscapes across nations that are partially explained by their diverse economic, clinical, and research settings. ...

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Section: Methodsmentioning

confidence: 99%

Integrated Real-World Data Warehouses Across 7 Evolving Asian Health Care Systems: Scoping Review

Shau,

Santoso,

Jip

et al. 2024

J Med Internet Res

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“…We used the RWD database, which is maintained by the Health, Clinic, and Education Information Evaluation Institute (HCEI, Kyoto, Japan) with support from Real World Data Co., Ltd. (Kyoto, Japan). This database is described in detail elsewhere 17–19 . Briefly, the RWD database is an electronic medical records (EMR) database containing anonymized data of over 20.6 million patients from 190 medical institutions across Japan as of August 2020 20 .…”

Section: Methodsmentioning

confidence: 99%

“…This database is described in detail elsewhere. [17][18][19] Briefly, the RWD database is an electronic medical records (EMR) database containing anonymized data of over 20.6 million patients from 190 medical institutions across Japan as of August 2020. 20 The stored information includes data on demographics, diagnoses, procedures, medications, and laboratory test results from both outpatient and inpatient services.…”

Section: Data Sourcementioning

confidence: 99%

Risk of parkinsonism and related movement disorders with gabapentinoids or tramadol: A case‐crossover study

Fukasawa

Yoshida

et al. 2023

Pharmacotherapy

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Introduction A safety signal concerning parkinsonism and related movement disorders with gabapentinoids (gabapentin and pregabalin) or tramadol was detected by reviewing individual case reports and data mining in spontaneous report databases. Well‐designed pharmacoepidemiological studies are needed to assess the signal. Objective This study aimed to investigate the association of exposure to gabapentinoids or tramadol with the risk of parkinsonism and related movement disorders. Methods We conducted a case‐crossover study using a Japanese electronic medical records database. Patients with newly diagnosed parkinsonism or related movement disorders between January 1, 2007, and April 14, 2019, were identified. The diagnosis date of outcomes was defined as the index date. We assessed the exposure of each patient to gabapentinoids or tramadol during a 90‐day hazard period ending 1 day before the index date and in three 90‐day reference periods. Multivariable conditional logistic regression models were employed to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs). To confirm the robustness of the primary findings, we also performed sensitivity analyses using a case–case‐time‐control design, a different time window for hazard and reference periods, a different definition of outcome, and different number of reference periods. Results A total of 28,972 eligible cases were included in the primary analysis. Exposure to gabapentinoids (aOR, 2.12; 95% CI, 1.73–2.61) and tramadol (aOR, 2.04; 95% CI, 1.57–2.64) was associated with increased risk. Results were consistent across sensitivity analyses. Conclusion Our findings serve as a caution to physicians who prescribe gabapentinoids or tramadol in routine clinical practice.

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“…These diagnoses, prescriptions, and procedures are coded using the International Classification of Diseases, Tenth Revision (ICD-10) codes, the Anatomical Therapeutic Chemical (ATC) codes together with the Japan-specific YJ (Yakka Joho) codes (code according to the National Health Insurance Drug List), and the Japanese procedure codes. The advantage of the JMDC database is its ability to track an individual’s medical information across different healthcare facilities under the same health insurance, making it widely used for epidemiology studies in Japan (Fukasawa et al, 2023; Masuda et al, 2023; S. Yoshida et al, 2022).…”

Section: Methodsmentioning

confidence: 99%

Cardiovascular Safety of Atomoxetine and Methylphenidate in Patients With Attention-Deficit/Hyperactivity Disorder in Japan: A Self-Controlled Case Series Study

Zheng,

Fukasawa,

Yamaguchi

et al. 2023

J Atten Disord

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Objective: To investigate the association between atomoxetine or methylphenidate use and arrhythmia, heart failure (HF), stroke, and myocardial infarction (MI) in attention-deficit/hyperactivity disorder (ADHD) patients mainly focused on the people of working age. Methods: In a self-controlled case series study using a Japanese claims database, we identified events of arrhythmia, HF, stroke, and MI among 15,472 atomoxetine new users and 12,059 methylphenidate new users. Adjusted incidence rate ratios (aIRRs) of outcome events were estimated using multivariable conditional Poisson regression. Results: An increased risk of arrhythmia was observed during the first 7 days after the initial atomoxetine exposure (aIRR 6.22, 95% CI [1.90, 20.35]) and in the subsequent exposure (3.23, [1.58, 6.64]). No association was found between methylphenidate exposure and arrhythmia, nor between atomoxetine or methylphenidate exposure and HF. The limited number of stroke and MI cases prevented thorough analysis. Conclusions: Clinicians should consider monitoring for arrhythmia after patients initiating or re-initiating atomoxetine.

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Clinical epidemiology and pharmacoepidemiology studies with real-world databases

Cited by 17 publications

References 101 publications

Integrated Real-World Data Warehouses Across 7 Evolving Asian Health Care Systems: Scoping Review

Integrated Real-World Data Warehouses Across 7 Evolving Asian Health Care Systems: Scoping Review

Risk of parkinsonism and related movement disorders with gabapentinoids or tramadol: A case‐crossover study

Cardiovascular Safety of Atomoxetine and Methylphenidate in Patients With Attention-Deficit/Hyperactivity Disorder in Japan: A Self-Controlled Case Series Study

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